MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-03-15 for PERIFIX CUSTOM EPIDURAL ANESTHESIA TRAY CESK 551508 manufactured by B. Braun Medical.
[727493]
As reported by the sales rep per the user facility. The tip of the catheter broke off when removed. Additional info provided by the facility indicated the pt suffered no additional adverse sequela associated with the incident. The catheter tip was not located on x-ray and it is uncertain if the catheter tip remains in the pt or if it was lost during removal.
Patient Sequence No: 1, Text Type: D, B5
[7863320]
The actual device involved in the incident was not returned to the mfr to evaluate. Without the sample a thorough eval could not be performed. No specific conclusions can be drawn. It should be noted, the instructions for use supplied with this product indicate "caution: do not withdraw catheter through needle due to possible danger of shearing. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523676-2007-00012 |
| MDR Report Key | 911255 |
| Report Source | 06 |
| Date Received | 2007-03-15 |
| Date of Report | 2007-03-09 |
| Date of Event | 2007-01-15 |
| Date Mfgr Received | 2007-01-19 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2007-09-13 |
| 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 | 0 |
| Manufacturer Contact | KIKOO TEJWANI |
| Manufacturer Street | 901 MARCON BLVD. |
| Manufacturer City | * 18109 |
| Manufacturer Country | * |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 2660500 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIFIX CUSTOM EPIDURAL ANESTHESIA TRAY |
| Generic Name | CUSTOM EPIDURAL KIT |
| Product Code | GZD |
| Date Received | 2007-03-15 |
| Model Number | CESK |
| Catalog Number | 551508 |
| Lot Number | 60875854 |
| ID Number | NA |
| Device Expiration Date | 2008-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 884910 |
| Manufacturer | B. BRAUN MEDICAL |
| Manufacturer Address | * ALLENTOWN PA 18109 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-03-15 |