FLEXIMA NEPHROSTOMY CATHETER SYSTEM
Report
- Report Number
- 2134265-2010-03634
- Event Type
- Malfunction
- Date Received
- August 12, 2010
- Report Date
- July 16, 2010
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- FFA
- PMA / PMN Number
- K944290
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
DEVICE EVALUATED BY MANUFACTURER: RECEIVED ONE FLEXIMA NEPH 14F/25CM REG KIT IN ORIGINAL UNOPENED POUCH WITH PRODUCT LABEL. THE ORIGINAL PRODUCT POUCH WAS UNOPENED INDICATING THE DEVICE OR COMPONENTS WERE NOT USED. FROM A VISUAL EVALUATION, FIBER LIKE FOREIGN MATTER WAS FOUND INSIDE THE SEALED POUCH NEAR THE PRODUCT TRAY. THE PRODUCT PACKAGING POUCH, CATHETER DEVICE AND ALL OTHER COMPONENTS WERE FOUND TO BE INTACT. THE FOREIGN MATTER WAS FOUND TO BE LARGER THAN THE ALLOWABLE SIZE/ SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING. (B)(4).
DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)
IT WAS REPORTED THAT DURING VISUAL INSPECTION OF THE FLEXIMA NEPH 14F/25CM REG KIT AT THE WAREHOUSE THE CLERK NOTICED A "STRANGE BODY (LOOKING LIKE WOOL)" IN THE STERILE PACKAGE. THE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT DURING VISUAL INSPECTION OF THE FLEXIMA NEPH 14F/25CM REG KIT AT THE WAREHOUSE THE CLERK NOTICED A "STRANGE BODY (LOOKING LIKE WOOL)" IN THE STERILE PACKAGE. THE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXIMA NEPHROSTOMY CATHETER SYSTEM | TUBE, DRAINAGE, SUPRAPUBIC | FFA | BOSTON SCIENTIFIC - SPENCER | M001271890 | 13039991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |