MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-03 for DUAL LUMEN GROSHONG #60313 UNKNOWN manufactured by Bard Access Systems.
[4850]
Groshong catheter was removed and replaced on 9/29/93 after leadage was noted from both ports; a pathology report indicates 0. 2 cm laceration was noted 13 cm distal to the proximal end of the catheter. Patient developed small pneumothorax which was noted after replacement of catheter. Device 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 evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: other. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7689 |
| MDR Report Key | 7689 |
| Date Received | 1994-01-03 |
| Date of Report | 1993-10-04 |
| Date of Event | 1993-09-29 |
| Date Facility Aware | 1993-09-29 |
| Report Date | 1993-10-04 |
| Date Reported to Mfgr | 1993-09-29 |
| Date Added to Maude | 1994-05-09 |
| 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 | DUAL LUMEN GROSHONG #60313 |
| Generic Name | DUAL LUMEN CENTRAL CATHETER |
| Product Code | GBP |
| Date Received | 1994-01-03 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | 36BC4209 |
| ID Number | UNKNOWN |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 7368 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-01-03 |