MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-08-06 for PENCAN P27BK 333871 manufactured by B. Braun Medical, Inc..
[245315]
Pt seen in emergency for a retained foreign body in the lower back. In early 2001, pt had two anesthetics during labor using pencan spinal tray p27bk. Appears that one of the two introducer needles used in one of the two procedures separated from the introducer hub and was retained by the pt in the subcutaneous tissue/thoracolumbar fascia. The retained shaft was easily removed under local anesthesia with light sedation. The shaft appeared to be straight without evidence of bending or shearing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2001-00036 |
| MDR Report Key | 346243 |
| Report Source | 05 |
| Date Received | 2001-08-06 |
| Date of Report | 2001-08-01 |
| Date of Event | 2001-06-02 |
| Date Facility Aware | 2001-06-02 |
| Report Date | 2001-08-01 |
| Date Mfgr Received | 2001-07-09 |
| Date Added to Maude | 2001-08-13 |
| 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 |
| Manufacturer Contact | ANDREW HARAKAL |
| 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 | PENCAN TRAY |
| Product Code | HAS |
| Date Received | 2001-08-06 |
| Model Number | P27BK |
| Catalog Number | 333871 |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 335563 |
| 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 | 2001-08-06 |