MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-12-23 for PENCAN 560218 manufactured by B. Braun Medical, Inc..
[359778]
"in the customer kit, there is a spinal introducer needle and the needle detached from the hub and was buried in the pt. The needle was removed after an incision was made. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2003-00058 |
| MDR Report Key | 503016 |
| Report Source | 06 |
| Date Received | 2003-12-23 |
| Date of Report | 2003-12-18 |
| Date of Event | 2003-11-13 |
| Date Facility Aware | 2003-11-13 |
| Report Date | 2003-12-18 |
| Date Mfgr Received | 2003-11-19 |
| Date Added to Maude | 2003-12-30 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ART MORSE |
| Manufacturer Street | 901 MARCON BLVD |
| Manufacturer City | ALLENTOWN PA 18103 |
| Manufacturer Country | US |
| Manufacturer Postal | 18103 |
| Manufacturer Phone | 6102660500 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | CUSTOM SPINAL KIT |
| Product Code | HAS |
| Date Received | 2003-12-23 |
| Model Number | NA |
| Catalog Number | 560218 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 491788 |
| 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 | NA |
| Baseline Catalog No | 560218 |
| Baseline ID | NA |
| Baseline Device Family | CUSTOM 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 | 2003-12-23 |