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

Catalog Number 555296

Device Problems Material Frayed (1262); Material Separation (1562); Connection Problem (2900)

Patient Problem Pain (1994)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

As reported by the user facility through medwatch # (b)(4): "epidural catheter found to be separated and shredded between patient and filter.Anesthesia notified, attempted to cut clean edge with sterile scissors, but unable to make adequate connection with filter.Epidural catheter was replaced and the impact to the patient was interruption in pain management.What was the original intended procedure.Pain delivery prior to birth.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working).Device usage problem: other.".

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report # (b)(4).One used catheter, with packaging identifying the reported lot # 0061339395, was received for evaluation.However, only a partial fragment (approximately 17 cm) of the proximal end of the catheter was returned; the remainder of the catheter was not returned.The catheter was received attached to a catheter connector and syringe.The fractured end of the catheter was stretched/elongated, with part of the inner coil unwound and extending out from the fractured area.The damage observed appears consistent with the catheter being subjected to an excessive force which stretched and ultimately fractured the catheter.Review of the discrepancy management system database performed for the reported kit lot number and involved catheter lot did not reveal any abnormalities or nonconformances of this nature noted during in-process or final product inspection.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.Based on the examination of the returned sample, the damage observed does not appear to be the result of a manufacturing defect, but instead related to the catheter being stretched to the point of fracture.If additional pertinent information becomes available, a follow-up report will be filed.

• Brand Name: CUSTOM EPIDURAL ANESTHESIA TRAY
• Type of Device: 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: 3941046
• MDR Text Key: 4572071
• Report Number: 2523676-2014-00139
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 555296
• Device Lot Number: 0061339395
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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: 29 YR