MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX AND CONTIPLEX CATHETER; EPIDURAL CATHETER

Model Number 19 GAUGE PERIFIX FX CONTINUOUS

Device Problems Coiled (1098); Difficult to Remove (1528); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/27/2016

Event Type  malfunction  

Event Description

Crna attempted to insert epidural catheter unable to advance far enough in.Attempted to remove catheter, after 1 inch had been pulled out, resistance was met.Despite repositioning of patient, turning bevel of needle and removing the needle ,the catheter would not come out.After the needle was removed, tension was applied to the catheter and a coiled strand was removed.It did not appear as if the catheter was still completely intact.The catheter was measured against a new catheter and it is approx.3/4 inch shorter.A (b)(6) year old gravida 2 female admitted with decreased fetal movement and found with no amniotic fluid (bbp 6 of 8).Labor was induced using cervidil and pitocin.A second epidural catheter was inserted 2 levels above without difficulty.After delivery, the second epidural catheter was removed without difficulty.

• Brand Name: PERIFIX AND CONTIPLEX CATHETER
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; bethlehem PA 18018
• MDR Report Key: 5705313
• MDR Text Key: 46795150
• Report Number: MW5062698
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: 19 GAUGE PERIFIX FX CONTINUOUS
• Device Catalogue Number: CE17TKFCPS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 79