MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-10 for ESPOCAN? 333192 manufactured by B. Braun Medical Inc..
[67399429]
This report has been identified as b. Braun medical inc. Internal report number (b)(4). The investigation into this reported event is ongoing. A follow-up report will be submitted when the results of the investigation are available.
Patient Sequence No: 1, Text Type: N, H10
[67399430]
As reported by user facility: clinician inserted epidural catheter and thought it wasn't in the correct location. Clinician removed the epidural catheter and noticed the tip was missing from the epidural catheter.
Patient Sequence No: 1, Text Type: D, B5
[73576817]
(b)(4). The actual device involved in the reported incident was not returned for evaluation. Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn. While no specific conclusion can be drawn, incidents of this nature can occur if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter. As indicated in the instructions for use, the catheter should not be withdrawn through the needle because of the possible danger of shearing or kinking. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number. If additional pertinent information becomes available a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523676-2017-00015 |
| MDR Report Key | 6321765 |
| Date Received | 2017-02-10 |
| Date of Report | 2017-01-13 |
| Date of Event | 2017-01-12 |
| Date Mfgr Received | 2017-01-13 |
| Device Manufacturer Date | 2016-09-21 |
| Date Added to Maude | 2017-02-10 |
| 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 | MS. 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 | 2017-02-10 |
| Catalog Number | 333192 |
| Lot Number | 0061517627 |
| Device Expiration Date | 2018-04-30 |
| 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 | 2017-02-10 |