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 2017-02-17 for ESPOCAN? 333196 manufactured by B. Braun Medical Inc..
[67807467]
(b)(4). One used set was received for evaluation. The sample was visually evaluated and the reported shearing of the catheter was confirmed. While no specific conclusion can be drawn, incidents of this nature can occur if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter. As indicated in the instructions for use, the catheter should not be withdrawn through the needle because of the possible danger of shearing or kinking. Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature. 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
[67807468]
As reported by user facility: catheter sheared off into patient approximately 3mm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2017-00016 |
| MDR Report Key | 6339449 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-17 |
| Date of Report | 2017-01-20 |
| Date of Event | 2017-01-05 |
| Date Mfgr Received | 2017-01-20 |
| Device Manufacturer Date | 2016-10-24 |
| Date Added to Maude | 2017-02-17 |
| 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. BRIDSEIDA MELENDEZ |
| 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 | 2017-02-17 |
| Returned To Mfg | 2017-02-03 |
| Catalog Number | 333196 |
| Lot Number | 0061522587 |
| Device Expiration Date | 2018-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-02-17 |