MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-07-02 for PENCAN P25LBTK 333861 manufactured by B. Braun Medical, Inc..
[125372]
Medwatch form received from user facility states: "pt underwent a c-section with spinal anesthesia. During administration of the spinal anesthesia, the spinal needle was noted to break off. The 27 gauge needle was surgically removed without further problems. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 230111 |
| MDR Report Key | 230111 |
| Date Received | 1999-07-02 |
| Date of Report | 1999-05-26 |
| Date of Event | 1999-04-30 |
| Date Facility Aware | 1999-04-30 |
| Report Date | 1999-05-26 |
| Date Reported to Mfgr | 1999-05-26 |
| Date Added to Maude | 1999-07-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENCAN |
| Generic Name | PENCAN FULL SPINAL KIT |
| Product Code | HAS |
| Date Received | 1999-07-02 |
| Model Number | P25LBTK |
| Catalog Number | 333861 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 223172 |
| Manufacturer | B. BRAUN MEDICAL, INC. |
| Manufacturer Address | 901 MARCON BLVD. ALLENTOWN PA 18103 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-07-02 |