Device adverse event reports (MAUDE)

CLEARLINK · Set, administration, intravascular

BAXTER HEALTHCARE CORPORATION · Nonstandard Device

2026-09-30MalfunctionInitial submissionMDR 50941448

Manufacturer g1 address 2

APARTADO NO. 1-7052

Manufacturer contact state

Manufacturer link flag

Manufacturer g1 city

CARTAGO

Manufacturer contact address 1

25212 W. Illinois Route 120

Manufacturer contact pcity

+1(224)2

Event type

Malfunction

Report number

1416980-2026-03054

Product problem flag

Date received

20260930

PMA pmn number

K112893

Date of event

20260925

Reprocessed and reused flag

Manufacturer contact zip code

60073

Manufacturer contact plocal

+1(224)270-5355

Noe summarized

Manufacturer g1 state

Reporter country code

Date added

20260930

Device date of manufacturer

20250603

Previous use code

Reporter state code

Mfr report type

Thirty-Day

Manufacturer contact country

Date changed

20260930

Health professional

Summary report flag

Date report

20260929

Initial report to FDA

Manufacturer g1 country

Manufacturer contact city

Round Lake

MDR report key

50941448

Date manufacturer received

20260929

Report source code

Manufacturer report

Manufacturer g1 name

BAXTER HEALTHCARE - CARTAGO

Adverse event flag

Single use flag

Manufacturer g1 address 1

PARQUE INDUSTRIAL DE CARTAGO

Manufacturer contact postal code

60073

Type of report

Initial submission

Source type

Company representation

Device

Device sequence number
319556
Date received
20260930
Brand name
CLEARLINK
Generic name
Set, administration, intravascular
Manufacturer d name
BAXTER HEALTHCARE CORPORATION
Manufacturer d city
DEERFIELD
Manufacturer d state
IL
Device operator
OTHER
Model number
2N8371
Catalog number
2N8371
Lot number
R25F03017
Device availability
Yes
Date returned to manufacturer
20260907
Device report product code
FPA
Device evaluated by manufacturer
N
Combination product flag
N
UDI di
00085412048925
UDI public
(01)00085412048925(10)R25F03017
Harmonized identifiers (openFDA)
Device name
Set, Administration, Intravascular
Medical specialty description
General Hospital
Regulation number
880.5440
Device class
2

Product problems

Nonstandard Device

Patient

Patient sequence number
1
Date received
20260930
Patient sex
Unknown
Patient problems
No Clinical Signs, Symptoms or Conditions

How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.