MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-02-26 for PENCAN? 333851 manufactured by B. Braun Medical Inc..
[101000771]
(b)(4). The sample has not yet been received and the investigation is ongoing at this time. A follow-up report will be submitted when the results of the investigation become available.
Patient Sequence No: 1, Text Type: N, H10
[101000772]
As reported by the user facility: during insertion of the spinal needle at the l4/l5 level, the needle broke off and a piece was retained. The distal portion of the needle was noted to be missing upon removal. It was a difficult insertion but the procedure was successful. Intervention to remove the foreign body was initially attempted but was then aborted. It is not expected to cause any problem or issue. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2018-00010 |
| MDR Report Key | 7297740 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-26 |
| Date of Report | 2018-03-23 |
| Date Mfgr Received | 2018-02-07 |
| Date Added to Maude | 2018-02-26 |
| 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 | JONATHAN SEVERINO |
| Manufacturer Street | 901 MARCON BLVD |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4847197287 |
| 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 | 2018-02-26 |
| Returned To Mfg | 2018-02-27 |
| Catalog Number | 333851 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2018-02-26 |