MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-06-17 for CONTIPLEX 331693 manufactured by B. Braun Medical, Inc..
[1408669]
As reported by the user facility: received call from nurse seeking suggestion how to remove the catheter from pt's groin. The pt had received a thermal nerve cath in his left groin, lateral to thigh. Due to some skin graft of some sort, the catheter was awkwardly placed. Denies physician having any resistance when threading cath, although nurse noted this physician tends to thread caths deep. Additional info provided by the facility indicated the catheter was looped in the pt around tissue and was surgically removed without incident. The pt suffered no adverse sequela associated with the incident and was discharged. The customer stated that the incident was due to end user error and it was definitely not the product. The sample was discarded and the lot number remains unk.
Patient Sequence No: 1, Text Type: D, B5
[8578363]
The actual catheter was not returned to the mfr to be evaluated and a lot number was not provided. However, the facility did return a photograph for evaluation. The photo depicted the catheter looped and knotted into the configuration of a noose. The customer stated that this incident was due to end user error and it was definitely not the product. Based on the customer's statement, the event description, and the photograph evaluation, this incident can be attributed to user/product interaction. There are no other reports of this nature against the reported catalog number. The photograph and all available info has been provided to the actual mfr for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523676-2010-00043 |
| MDR Report Key | 1730950 |
| Report Source | 06 |
| Date Received | 2010-06-17 |
| Date of Report | 2010-06-01 |
| Date of Event | 2010-04-17 |
| Date Mfgr Received | 2010-05-18 |
| Date Added to Maude | 2010-06-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIMBERLY PARIS |
| Manufacturer Street | 901 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 6102660500 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTIPLEX |
| Generic Name | TUOHY CONTINUOUS NERVE BLOCK SET |
| Product Code | BXN |
| Date Received | 2010-06-17 |
| Model Number | NA |
| Catalog Number | 331693 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL, INC. |
| Manufacturer Address | ALLENTOWN PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-06-17 |