MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for PENCAN 333868 manufactured by B. Braun Medical Inc..
[100799762]
Patient Sequence No: 1, Text Type: N, H10
[100799763]
Patient received a spinal prior to c-section. Marcaine in the kit failed to give a sufficient block. A second kit had to be opened and another block had to be performed to effectively meet the patients analgesia needs. Manufacturer response for pencan spinal needle tray, (brand not provided) (per site reporter). Nature of marcaine and yes it suggests that the drug is unstable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7292000 |
| MDR Report Key | 7292000 |
| Date Received | 2018-02-23 |
| Date of Report | 2018-01-18 |
| Date of Event | 2017-11-30 |
| Report Date | 2018-01-18 |
| Date Reported to FDA | 2018-01-18 |
| Date Reported to Mfgr | 2018-01-18 |
| 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 |
| 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 | 2018-02-23 |
| Catalog Number | 333868 |
| ID Number | PRODUCT CODE: P24BK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 |