FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 4090174
·
Received September 15, 2014
Report
- Report Number
- 1416980-2014-31307
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Date of Event
- August 11, 2014
- Report Date
- August 21, 2014
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION WITHIN AN UNOPENED POUCH. DURING VISUAL INSPECTION A TEAR WAS OBSERVED AT THE CENTER OF THE POUCH. THE REPORTED PROBLEM WAS VERIFIED. A CAPA HAS BEEN OPENED FOR THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN INTERLINK CATHETER EXTENSION SET HAD A TORN OVERPOUCH. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568548 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - SINGAPORE | SR14A29019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |