MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PERIFIX CONTINUOUS EPIDURAL TRAY; PERIFIX 19 GA. FX EPIDURAL CATHETER

Model Number CE17TKFCS

Device Problems Detachment Of Device Component (1104); Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

As requested by the user facility through medwatch #360179-2015-001: "after delivery of infant when rn removed epidural catheter, the tip was not intact on the catheter and the end was frayed.The epidural catheter was removed with no resistance.Dr (b)(6), anesthesiologist, was notified by rn to come to eval pt.No palpable mass was noted by him.He explained to the pt there would be imaging studies done the next day to further evaluate.Dr (b)(6) notified the attending ob physician.Pt denied any numbness or tingling anywhere." f/u correspondence with the reporting facility indicated an x-ray confirmed the tip is still embedded in the pt.The tip was unable to be retrieved.The pt has no injuries or ill effects as a result.The reporter indicated they cannot release the sample, but will provide a picture.

Manufacturer Narrative

This report has been identified as b braun medical inc., (b)(4).The actual device involved in the reported incident was not returned for eval.However, a photo of the involved catheter was sent.Based on the returned photo, the catheter appeared fractured with part of the inner coil unwound and extending out of the fractured end of the catheter.The area at the fracture appeared stretched.However, no specific conclusions could be drawn from the photo.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becomes lodged between rigid body structures and is stretched beyond its design capabilities, or if the catheter is withdrawn or partially withdrawn through the needle, thereby sheering the catheter.Per the instructions for use (ifu) for the reported product catalog number, "caution: do not withdraw catheter through needle because of the possible danger of shearing." no adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or catheter material number.If add'l pertinent info becomes available, a f/u report will be filed.

• Brand Name: PERIFIX CONTINUOUS EPIDURAL TRAY
• Type of Device: PERIFIX 19 GA. FX EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 4544433
• MDR Text Key: 5508568
• Report Number: 2523676-2015-00038
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CE17TKFCS
• Device Catalogue Number: 332097
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 67