MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-18 for PERIFIX FX SPRINGWOUND EPIDURAL CATHETERS EC19CF 333512 manufactured by B. Braun Medical, Inc..
[3622787]
As reported by the user facility: reports the tip of catheter broke off in a pt. An x-ray was done to determine the position of the tip of the catheter, but it wasn't detected on the x-ray. The staff states, "when it was clearly taut. When they pulled the catheter, it looked stretched. When it was completely removed, the blue tip was missing. It was definitely stretched out from removing. " the staff also stated, "that we do what we normally do when removing it. So there has been no change in removal procedure. " no pt injury; pt had no complications. During f/u correspondence with the facility, the reporter indicated that no medical intervention was required, and that the pt was doing fine at discharge.
Patient Sequence No: 1, Text Type: D, B5
[10914586]
(b)(4). The actual device involved in the reported incident has not yet been returned for eval. Without the actual sample or lot number, a thorough eval could not be performed and no specific conclusions can be drawn. The event description did indicate that the catheter was clearly taut and appeared stretched. While no specific conclusion can be drawn, incidents of this nature can occur when a catheter becomes lodged between rigid body structures and is stretched beyond its design capabilities. No adverse quality trends of this nature were identified during the complaint review process for the product catalog number identified in the reported event. If the sample is received or if add'l pertinent info becomes available, a f/u report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523676-2013-00217 |
| MDR Report Key | 3264615 |
| Report Source | 05,06 |
| Date Received | 2013-07-18 |
| Date of Report | 2013-06-20 |
| Date of Event | 2013-05-30 |
| Date Mfgr Received | 2013-06-20 |
| Date Added to Maude | 2013-10-16 |
| 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 | ROBERT HUBERT |
| 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 | PERIFIX FX SPRINGWOUND EPIDURAL CATHETERS |
| Generic Name | EC19CF 19G X 100CM CATH CLOSED TIP LF |
| Product Code | BSN |
| Date Received | 2013-07-18 |
| Model Number | EC19CF |
| Catalog Number | 333512 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2013-07-18 |