MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX FX SPRINGWOUND EPIDURAL CATHETER; PERIFIX 19 GA. FX EPIDURAL CATHETER

Model Number EC19CF

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 08/22/2015

Event Type  malfunction  

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.Without the actual sample or lot number, a thorough evaluation could not be performed and no specific conclusions can be drawn.The event description did indicate that tension was felt and the catheter began to stretch during removal.While no specific conclusions 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becomes lodged between rigid body structures and is stretched beyond its design capabilities; or if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Per the instructions for use (ifu) for the reported product catalog number, "do not withdraw the catheter through the needle due to the possibility of shearing or kinking." 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 tip broke off during removal.There were no complications on the insertion of the catheter.The patient was hunched over and fidgeting around during removal.There was tension noticed in the catheter and the patient was redirected to bend over more.After the patient bent over more, there was still tension during the removal.The catheter started to stretch and then it broke off in the patient.The metal wire was removed and started recoiling.The patient was taken for a ct scan and something was noted in the epidural space; it is unknown if it was metal or the plastic covering over the metal.The patient was not complaining of any pain or discomfort.The patient was instructed to avoid mri unless the piece is removed.At this time, the patient has not had the piece removed.

• Brand Name: PERIFIX FX SPRINGWOUND EPIDURAL CATHETER
• Type of Device: PERIFIX 19 GA. 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: 5071003
• MDR Text Key: 26073377
• Report Number: 2523676-2015-00393
• 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,user faci
• Reporter Occupation: Physician
• Report Date: 08/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC19CF
• Device Catalogue Number: 333512
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• 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