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

Model Number CE17TKFCPS

Device Problems Coiled (1098); Difficult to Remove (1528); Failure to Advance (2524); Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample, a thorough sample analysis could not be performed and no specific conclusions can be drawn.The event description did indicate that there was some difficulty with the insertion, and resistance was met when attempting to remove 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 reported catalog number or catheter material number.There were no other reports of this nature against the reported lot number.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported through medwatch # mw5062698: "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." during a follow-up phone call with the reporting facility, the reporter stated that a ct scan performed did not show anything in the patient.The facility will not release the sample of the catheter at this time.

• Brand Name: PERIFIX® CONTINUOUS EPIDURAL TRAY
• Type of Device: PERIFIX FX EPIDURAL 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: 5808143
• MDR Text Key: 50839472
• Report Number: 2523676-2016-00479
• 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,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: CE17TKFCPS
• Device Catalogue Number: 332078
• Device Lot Number: 0061476648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2016
• 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