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

Model Number CE18TK

Device Problems Break (1069); Material Fragmentation (1261); Component Missing (2306); Physical Resistance (2578)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/18/2016

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 tip appeared to be fractured and missing.However, no specific conclusions can be drawn from the photo.Without the actual used sample, a thorough sample analysis could not be performed.The event description did indicate that resistance was met while placing 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becomes lodged between rigid body structures and is stretched beyond its design capabilities; or if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Per the instructions for use (ifu) for the reported product catalog number, "do not withdraw catheter through the needle because of the possible danger of shearing." 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.All available information has been forwarded to the device manufacturer of the catheter.If additional pertinent information becomes available or if the physical sample is received for evaluation, a follow-up report will be filed.

Event Description

As reported by the user facility: reports while placing an epidural resistance was met.The needle and catheter were then withdrawn together.There was no resistance noted on withdrawal.Upon inspection of the catheter tip, approximately 2.6 cm of the catheter appeared missing.It was a very straight cut off of the catheter.The broken catheter fragment was retained in the patient's back muscle.At this time, the facility is not planning to remove the retained portion from the patient.The reporter also stated a colleague tried to duplicate the issue, and was also able to on a table with no forces at the same point on the catheter.

• Brand Name: PERIFIX® CONTINUOUS EPIDURAL TRAY
• Type of Device: PERIFIX EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 5725566
• MDR Text Key: 48501931
• Report Number: 2523676-2016-00347
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: CE18TK
• Device Catalogue Number: 332220
• Device Lot Number: 0061466920
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2016
• Initial Date FDA Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2015
• 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: 20 YR