FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 4973018
·
Received August 5, 2015
Report
- Report Number
- 1416980-2015-31525
- Event Type
- Malfunction
- Date Received
- August 5, 2015
- Date of Event
- July 14, 2015
- Report Date
- July 14, 2015
- Manufacturer
- BAXTER HEALTHCARE - AIBONITO
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A ONE-LINK BECAME DISCONNECTED FROM THE PATIENT¿S PERIPHERALLY INSERTED CENTRAL CATHETER. THIS OCCURRED SHORTLY AFTER THE ONE-LINK WAS CHANGED AND AN UNKNOWN ANTIBIOTIC WAS ADMINISTERED. THERE WAS LIMITED BLOOD LOSS, HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513112 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - AIBONITO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PERIPHERALLY INSERTED CENTRAL CATHETER (PICC LINE) |