FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3170671
·
Received June 14, 2013
Report
- Report Number
- 1416980-2013-15404
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Report Date
- May 22, 2013
- Manufacturer
- BAXTER HEALTHCARE - AIBONITO
- Product Code
- FPA
- PMA / PMN Number
- K112893
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CLEARLINK CATHETER EXTENSION SET EXPERIENCED NO FLOW WHEN USED WITH A NON-BAXTER BLOOD COLLECTION DEVICE. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NOT PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271848 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - AIBONITO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | BLOOD DRAW SAF-T HOLDER DEVICE |