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

Model Number CE18TKST

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problems Tingling (2171); Device Embedded In Tissue or Plaque (3165)

Event Date 02/14/2015

Event Type  malfunction  

Event Description

As reported by the user facility: reports during placement of catheter, the pt complained of paresthesia as the catheter was threaded.The catheter was pulled out and the needle was redirected.The catheter was placed again, and the pt again complained of paresthesia.As the catheter was being pulled back, the catheter broke off at 6 cm.An mri was performed, but unable to find the catheter fragment.The pt's bmi is 50.A decision was made to leave the catheter in the pt.The pt was asymptomatic.

Manufacturer Narrative

This report has been identified as b.Braun medical inc., internal report # (b)(4).One used catheter fragment was received for eval.The catheter appeared fractured, measuring approx 37.5 inches.Based on the spec for the catheter overall length, approx 2.5 inches of the catheter tip end was missing.Under microscopic observation, the fractured end of the catheter was smooth and angular in appearance.This type of cut is consistent with a potential damage noted when the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Review of the discrepancy management system database performed for the reported lot number did not reveal any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 info has been forwarded to the device mfr of the catheter.If add'l pertinent info becomes available, a f/u report will be filed.

• Brand Name: PERIFIX CONTINUOUS EPIDURAL TRAY
• Type of Device: PERIFIX 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: 4740607
• MDR Text Key: 5827377
• Report Number: 2523676-2015-00146
• 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 Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: CE18TKST
• Device Catalogue Number: 332081
• Device Lot Number: 0061402179
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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