MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for PENCAN manufactured by B. Braun Medical Inc.
[100809706]
Patient Sequence No: 1, Text Type: N, H10
[100809707]
B. Braun made changes in pencan packaging and excluded epinephrine. The multiple sets are missing introducer multiple sets.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7292254 |
| MDR Report Key | 7292254 |
| Date Received | 2018-02-23 |
| Date of Report | 2018-01-09 |
| Date of Event | 2017-12-15 |
| Report Date | 2017-12-26 |
| Date Reported to FDA | 2017-12-26 |
| Date Reported to Mfgr | 2017-12-26 |
| Date Added to Maude | 2018-02-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 2018-02-23 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 0061579375 |
| Device Expiration Date | 2019-05-31 |
| Device Availability | N |
| 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 | 2018-02-23 |