MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-18 for ESPOCAN? 333192 manufactured by B. Braun Medical, Inc..
[133524233]
The glass syringe that is included in the kit leaks backwards. This creates friction and added tension when they try to advance the fluid in the syringe. They cannot accurately judge if their catheter is in the correct space without being able to have the appropriate tension when advancing the syringe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8260219 |
| MDR Report Key | 8260219 |
| Date Received | 2019-01-18 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-12-11 |
| Report Date | 2018-12-20 |
| Date Reported to FDA | 2018-12-20 |
| Date Reported to Mfgr | 2019-01-18 |
| Date Added to Maude | 2019-01-18 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ESPOCAN? |
| Generic Name | SPINAL EPIDURAL ANESTHESIA KIT |
| Product Code | OFT |
| Date Received | 2019-01-18 |
| Model Number | 333192 |
| Catalog Number | 333192 |
| Lot Number | 0061631522 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-01-18 |