FDA Adverse Event
Malfunction
Summary report: N
WECK HEMOCLIP LIGATING CLIPS, TITANIUM, SMALL
MDR report key: 2193603
·
Received July 13, 2011
Report
- Report Number
- 3003898360-2011-00297
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- April 22, 2011
- Report Date
- July 1, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- FZP
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL: METHOD - DHR REVIEW PERFORMED. A PHOTO VISUAL EXAMPLE PROVIDED SHOWS THE PACKAGE IS DAMAGED/TORN, CONFIRMING DEFECT REPORTED. RESULTS - THE DHR REVIEW REVEALED THAT NO SIMILAR ISSUES WERE FOUND DURING MFG OR PACKAGE PROCESS OF THIS LOT. CONCLUSIONS - NO SAMPLES IS REQUIRED TO CONFIRM DEFECT REPORTED. DEFECT REPORTED REPRESENT .01% DEFECTIVE OF LOT REPORTED. NO SAMPLE DISPOSITION IS REQUIRED SINCE THERE WAS NO PRODUCT RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: INCOMING INSPECTION ALLEGED ISSUE: "PACKAGE WAS FOUND TORN DURING INSPECTION." NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WECK HEMOCLIP LIGATING CLIPS, TITANIUM, SMALL | LIGATING CLIP | FZP | TELEFLEX MEDICAL | 01E1000480 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |