MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-04-20 for ESPOCAN? 333165 manufactured by B. Braun Medical Inc..
[73237000]
(b)(4). The device involved has not been received for evaluation and 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
[73237001]
As reported by the user facility: customer reports, while withdrawing epidural needle it met resistance and turned a 1/8 turn to overcome. After needle removed catheter measured 40 at skin level started to pull it back to 30 mark and catheter sheared at 37 mark. A new spinal was placed by anesthiologist and surgery completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2017-00060 |
| MDR Report Key | 6507073 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-05 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2017-04-05 |
| Device Manufacturer Date | 2017-01-09 |
| Date Added to Maude | 2017-04-20 |
| 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 |
| 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 | 6102660500 |
| 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 | 2017-04-20 |
| Model Number | 333165 |
| Catalog Number | 333165 |
| Lot Number | 0061537830 |
| Device Expiration Date | 2018-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-04-20 |