MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-10 for CONTIPLEX? 332143 manufactured by B. Braun Medical Inc..
[123499981]
This report has been identified as b. Braun medical internal report number (b)(4). Multiple unsuccessful attempts were made to obtain a sample and/or lot number. Without the actual device, a thorough investigation could not be performed. We will maintain this report for further references and continue to monitor other reports for similar occurrences. If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[123499982]
As reported by the user facility: complaint: anesthesiologist stated that approximately 3 cm of a polyamide catheter tip remained in patient after placement of a continuous peripheral nerve block (adductor block). Anesthesiologist stated she felt some resistance during placement of needle and catheter. It felt like the catheter was "stuck in the needle" and upon removal of the needle and catheter, it was noted that the tip of the catheter had "sheared" off. Anesthesiologist was concerned about the broken tip that remained in the patient as the patient was currently in the operating room for surgery. No recommendation was given. Customer was provided with type of catheter - polyamide and informed the catheter is biocompatible. Injury - broken tip of catheter remained in patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2018-00080 |
| MDR Report Key | 7953688 |
| Date Received | 2018-10-10 |
| Date of Report | 2018-10-10 |
| Date of Event | 2018-09-13 |
| Date Mfgr Received | 2018-09-13 |
| Device Manufacturer Date | 2018-05-01 |
| Date Added to Maude | 2018-10-10 |
| 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 |
| 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 | 0 |
| Brand Name | CONTIPLEX? |
| Generic Name | NERVE BLOCK TRAY (KIT) |
| Product Code | OGJ |
| Date Received | 2018-10-10 |
| Catalog Number | 332143 |
| Lot Number | 0061599649 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-10-10 |