MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for SPINAL NEEDLE 04046964180590 manufactured by B Braun Medical Inc..
[175085711]
Pt was scheduled for surgery spinal anesthetic with general anesthesia backup. During the removal of the needle, the tip of the needle was noted to be missing. X-ray confirmed 1/3 of the needle was lodged in the subcutaneous tissue. Md was notified of event and needle was remove under geta. Physician was able to locate the needle in the deep fascia and verified it was bent. Wound irrigated and needle sent to pathology. Per pathology report (b)(6) 2020, foreign body needle removal-container contains a bent needle measuring 4. 5cm in length. Mfr's name: b. Braun medical inc. , with a gtin# (b)(4) and lot# 00616990252, all are consistent with spinal needles. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092165 |
| MDR Report Key | 9580876 |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-09 |
| Date of Event | 2020-01-06 |
| Date Added to Maude | 2020-01-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPINAL NEEDLE |
| Generic Name | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) |
| Product Code | BSP |
| Date Received | 2020-01-10 |
| Model Number | 04046964180590 |
| Lot Number | 00616990252 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B BRAUN MEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-10 |