MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-05 for PENCAN? 333851 manufactured by B. Braun Medical Inc..
[99022885]
Patient Sequence No: 1, Text Type: N, H10
[99022886]
During insertion of the spinal needle, it broke off and a piece was retained. Unable to safely retrieve. Patient was about to receive spinal anesthesia. I believe it was at the l4/l5 level. The distal portion of the needle was noted to be missing upon removal. It was a difficult insertion but the procedure was successful. Not noted until procedure was complete and needle was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7240671 |
| MDR Report Key | 7240671 |
| Date Received | 2018-02-05 |
| Date of Report | 2018-02-01 |
| Date of Event | 2017-09-19 |
| Report Date | 2018-02-02 |
| Date Reported to FDA | 2018-02-02 |
| Date Reported to Mfgr | 2018-02-02 |
| Date Added to Maude | 2018-02-05 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 | PENCAN? |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2018-02-05 |
| Model Number | 333851 |
| Catalog Number | 333851 |
| ID Number | 25 GAUGE X 3 1/2 INCH SPINAL |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Manufacturer Address | 901 MARCON BLVD. ALLENTOWN PA 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-05 |