FDA Adverse Event
Malfunction
Summary report: N
FLEXICAP
MDR report key: 6046722
·
Received October 21, 2016
Report
- Report Number
- 1416980-2016-16487
- Event Type
- Malfunction
- Date Received
- October 21, 2016
- Date of Event
- September 28, 2016
- Report Date
- December 1, 2016
- Manufacturer
- BAXTER HEALTHCARE - SWINFORD
- Product Code
- KDJ
- PMA / PMN Number
- K152129
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
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 NOT RETURNED; 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 THE FLEXICAP HAD INADEQUATE IODINE IN IT. THE PATIENT STATED THAT WHEN THEY WERE GETTING THE CAP READY TO CONNECT, THEY NOTICED THAT IT DID NOT HAVE AS MUCH IODINE AS THEY USUALLY SEE IN IT. 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 |
|---|---|---|---|---|---|---|---|
| 699784 | FLEXICAP | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE | KDJ | BAXTER HEALTHCARE - SWINFORD | NA | 16A18H25 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |