FDA Adverse Event
Malfunction
Summary report: N
J-VAC RESERVOIR
MDR report key: 1163397
·
Received September 10, 2008
Report
- Report Number
- 2210968-2008-00791
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- August 4, 2008
- Report Date
- August 6, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- GCY
- PMA / PMN Number
- K953655
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
INTERNATIONAL CUSTOMER REPORTED THAT THE DEVICE LEAKED AIR AT THE CONNECTOR SIX DAYS FOLLOWING INITIAL ACTIVATION OF THE DEVICE. THE RESERVOIR WAS REMOVED FROM SERVICE AND EXCHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | J-VAC RESERVOIR | WOUND DRAINAGE SYSTEM | GCY | ETHICON, INC. | NA | JT7165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | DRAIN - SURGICAL |