MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX CONTINUOUS EPIDURAL TRAY; PERIFIX 20 GA. EPIDURAL CATHETER

Model Number CE18TKCDLS

Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2014

Event Type  Injury  

Event Description

As reported by the user facility through medwatch (b)(4): report repeat c-section with use of epidural anesthesia.Upon discontinuation of the epidural catheter, it was noted that the blue tip was not present on the end of the epidural catheter.It appears to have stretched when lined up next to a non-used catheter of the same type.A follow-up ct did not reveal presence of the catheter.The neurosurgeon did not feel intervention was required.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.(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 the catheter appeared stretched when compared to an unused 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 it's 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 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 a physical sample is received or if additional pertinent information becomes available, a follow-up report will be filed.

• Brand Name: PERIFIX CONTINUOUS EPIDURAL TRAY
• Type of Device: PERIFIX 20 GA. 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: 4208720
• MDR Text Key: 4963835
• Report Number: 2523676-2014-00382
• 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: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: CE18TKCDLS
• Device Catalogue Number: 332209
• Device Lot Number: 0061364311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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