MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-04 for JACKSON-PRATT DRAIN N/A SU 130-1311 manufactured by V. Mueller.
[1295]
Jackson pratt drain was recharged by nursing personnel at 0600 on 10/17/92 without incident. Surgeon attempted to remove drain at 0730 on 10/17/92. Suddenly, after cutting the sutures, there was a "snap" sound. The distal end of the drain entered the wound and was not visible. The patient returned to surgery on 10/17/92. The entire retained drain was removeddevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1642 |
| MDR Report Key | 1642 |
| Date Received | 1992-11-04 |
| Date of Report | 1992-10-22 |
| Date of Event | 1992-10-17 |
| Date Facility Aware | 1992-10-17 |
| Report Date | 1992-10-22 |
| Date Reported to FDA | 1992-10-22 |
| Date Reported to Mfgr | 1992-10-22 |
| Date Added to Maude | 1992-11-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JACKSON-PRATT DRAIN |
| Generic Name | UNKNOWN |
| Product Code | BYH |
| Date Received | 1992-11-04 |
| Model Number | N/A |
| Catalog Number | SU 130-1311 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 1559 |
| Manufacturer | V. MUELLER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-11-04 |