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

Catalog Number 530024

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/02/2014

Event Type  Injury  

Event Description

As reported by the user facility: reports the anesthesia provider had an issue with the epidural catheter, but the issue was unk at the time.During a follow-up call with the facility, the doctor reported that the crna placed the epidural catheter in laboring pt.When tried to readjust, resistance was felt and the catheter did snap leaving about 7cm of the catheter in the pt.This was confirmed on a follow-up ct scan with the neurosurgeon.No intervention is planned.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report # (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample, a thorough evaluation could not be performed and no specific conclusions can be drawn.The event description did indicate that resistance was felt when trying to readjust 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.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 product 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 a physical sample is received or if additional pertinent info becomes available, a follow-up report will be filed.

• Brand Name: CUSTOM EPIDURAL ANESTHESIA 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: 4257358
• MDR Text Key: 5110251
• Report Number: 2523676-2014-00409
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 530024
• Device Lot Number: 0061376392
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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
• Patient Outcome(s): Other