FDA Adverse Event
Malfunction
Summary report: N
J-VAC RESERVOIR
MDR report key: 2883174
·
Received December 21, 2012
Report
- Report Number
- 2210968-2012-08374
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- December 4, 2012
- Report Date
- December 4, 2012
- Manufacturer
- ETHICON, INC.
- Product Code
- KOG
- PMA / PMN Number
- K953655
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Additional Manufacturer Narrative · 1
(B)(4). 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PACKAGE WAS RECEIVED WITH A SLIT IN THE PACKAGE ON (B)(6) 2012. THIS WAS NOTICED PRIOR TO USE ON A PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | J-VAC RESERVOIR | ENDOSCOPE AND/OR ACCESSORIES | KOG | ETHICON, INC. | NA | JT7720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |