MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-04-12 for PENCAN P27BK 333871 manufactured by B. Braun Medical, Inc..
[21951511]
Medwatch report rec'd from the facility states: "dr. Attempting to do a spinal on pt. He was unable to locate a spinal space, and removed the needle. Part of the needle broke, and approx 1" remained in the pt. Another surgeon was called, and the pt was moved to another or where the fragment was surgically removed. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-1999-00007 |
| MDR Report Key | 218714 |
| Report Source | 06 |
| Date Received | 1999-04-12 |
| Date of Report | 1999-04-08 |
| Date of Event | 1999-03-05 |
| Date Facility Aware | 1999-03-05 |
| Report Date | 1999-04-08 |
| Date Reported to Mfgr | 1999-03-15 |
| Date Added to Maude | 1999-04-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENCAN |
| Generic Name | PENCAN SPINAL TRAY |
| Product Code | HAS |
| Date Received | 1999-04-12 |
| Model Number | P27BK |
| Catalog Number | 333871 |
| Lot Number | 876980 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 212118 |
| Manufacturer | B. BRAUN MEDICAL, INC. |
| Manufacturer Address | 901 MARCON BLVD. ALLENTOWN PA 18103 US |
| Baseline Brand Name | PENCAN |
| Baseline Generic Name | SPINAL TRAY |
| Baseline Model No | P27BK |
| Baseline Catalog No | 333871 |
| Baseline ID | NA |
| Baseline Device Family | PENCIL POINT SPINAL TRAY |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K932569 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-04-12 |