MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CUSTOM CONTIPLEX® NERVE BLOCK TRAY; 20 GAUGE ECHOGENIC CATHETER

Catalog Number 570246

Device Problems Material Fragmentation (1261); Knotted (1340)

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

Event Date 07/23/2015

Event Type  Injury  

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.However, the facility did return photos of the involved catheter.Based on the photos, the catheter tip appeared intact, but was knotted near the tip.The catheter appeared fractured several inches from the knotted area, with the inner coil unwound and stretched out.However, no specific conclusions can be drawn from the photos.Without the actual sample or lot number, a thorough evaluation could not be performed and no specific conclusions can be drawn.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becomes lodged between rigid body structures and is stretched beyond its design capabilities; or if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Per the instructions for use (ifu) for the reported product catalog number, "warning: pulling the catheter back into the needle increases the risk of catheter breakage and should be avoided if possible.If resistance is felt, do not attempt to pull back catheter, but remove catheter and needle as a single unit." no adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or involved catheter material number.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports the catheter broke when removing from the patient.The tip of the catheter appeared knotted.The patient had to return from 6+ hours away for a surgical cut down under general anesthesia.Further clarification obtained for this incident indicated that the patient had left the facility after the initial surgery.When the catheter was later removed, it broke.This required the patient to return to the facility (located 6+ hours away) to have the broken catheter fragment surgically removed.

• Brand Name: CUSTOM CONTIPLEX® NERVE BLOCK TRAY
• Type of Device: 20 GAUGE ECHOGENIC 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: 5051351
• MDR Text Key: 24893365
• Report Number: 2523676-2015-00360
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 570246
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention