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

Model Number CE17TKFC

Device Problems Material Fragmentation (1261); Unraveled Material (1664); Failure to Advance (2524)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.However, the facility did return a photo of the involved catheter.Based on the photo, the catheter appeared to be fractured / sheared at the tip end, with the inner coil unwound and stretched out at the area of the break.However, no specific conclusions can be drawn from the photo.The reporting facility indicated that there was resistance when attempting to pass the catheter.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becomes lodged between rigid body structures and is stretched beyond its design capabilities; or if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Per the instructions for use (ifu) for the reported product catalog number, "do not withdraw catheter through needle because of the possible danger of shearing or kinking." review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or catheter material number.There were no other reports of this nature against the reported lot number.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports patient was receiving an epidural in labor & delivery.While attempting to pass the catheter, it would not advance.When the catheter was removed, the blue tip was missing and the catheter unraveled.The sheared catheter tip currently remains in the patient.It is unsure at this time if the patient will electively remove the catheter fragment.

• Brand Name: PERIFIX® CONTINUOUS EPIDURAL TRAY
• Type of Device: PERIFIX FX EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: bridseida melendez ; 901 marcon blvd; allentown, PA 18109 ; 6102660500
• MDR Report Key: 6067346
• MDR Text Key: 59075329
• Report Number: 2523676-2016-00691
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: CE17TKFC
• Device Catalogue Number: 332079
• Device Lot Number: 0061510725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• 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: 38 YR