MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for PENCAN? 333851 manufactured by B. Braun Medical, Inc..
[136006062]
Anesthesiologist reports that the introducer needle in the spinal anesthesia kit does not allow for easy pass of spinal needle through it. Seems like there has been a change in manufacturing process. There is no bevel inside the hub of the introducer. This was not a substitute, it is the original product staff have been using. Per staff and anesthesia, it appears to be a specific lot#. Lot being pulled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8334843 |
| MDR Report Key | 8334843 |
| Date Received | 2019-02-13 |
| Date of Report | 2019-02-01 |
| Date of Event | 2019-01-31 |
| Report Date | 2019-02-01 |
| Date Reported to FDA | 2019-02-01 |
| Date Reported to Mfgr | 2019-02-13 |
| Date Added to Maude | 2019-02-13 |
| 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 | 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 | PENCAN? |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2019-02-13 |
| Model Number | 333851 |
| Catalog Number | 333851 |
| Lot Number | 0061649507 |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-02-13 |