MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2018-11-05 for ESPOCAN? 333192 manufactured by B. Braun Medical Inc..
[126646116]
This report has been identified as b. Braun medical internal report number (b)(4). Although it was confirmed that the device is not available for further evaluation, the investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.
Patient Sequence No: 1, Text Type: N, H10
[126646117]
As reported by the user facility: patient arrived to labor and deliver for c-section. Epidural catheter tip broke off during placement. The patient received an epidural catheter; catheter not believed to be in a functioning position. Upon removal, the catheter broke and 7. 5 cm was retained. A neurosurgical consult did determine that no surgical intervention was required at this time. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2018-00092 |
| MDR Report Key | 8037444 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2018-11-05 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-09-10 |
| Date Mfgr Received | 2018-10-22 |
| Device Manufacturer Date | 2018-04-30 |
| Date Added to Maude | 2018-11-05 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. 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 | ESPOCAN? |
| Generic Name | SPINAL EPIDURAL ANESTHESIA |
| Product Code | OFT |
| Date Received | 2018-11-05 |
| Catalog Number | 333192 |
| Lot Number | 0061615216 |
| Device Expiration Date | 2019-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-11-05 |