MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for BURRON MEDICAL INC. M 3712K manufactured by B. Braun Of America Co..
[912]
Using burron triple lumen catheter kit, surgeon inserted introducer, needle broke at "hub" and surgeon was able to retrieve the needle. Device labeled for single use. Patient medical status prior to event: critical 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: none or unknown, hub. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3357 |
| MDR Report Key | 3357 |
| Date Received | 1992-07-31 |
| Date of Report | 1992-05-14 |
| Date of Event | 1992-05-02 |
| Date Facility Aware | 1992-05-02 |
| Report Date | 1992-05-14 |
| Date Reported to Mfgr | 1992-05-14 |
| Date Added to Maude | 1993-04-16 |
| 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 | BURRON MEDICAL INC. |
| Generic Name | TRIPLE LUMEN CATHETER KIT |
| Product Code | GBP |
| Date Received | 1992-07-31 |
| Model Number | M 3712K |
| Lot Number | 430697 |
| ID Number | NEEDLE #M3706K |
| Device Expiration Date | 1994-06-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 3133 |
| Manufacturer | B. BRAUN OF AMERICA CO. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-31 |