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

Model Number CE17TKFC

Device Problems Material Fragmentation (1261); Unraveled Material (1664)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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.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becomes lodged between rigid body structures and is stretched beyond its design capabilities; or if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Per the instructions for use (ifu) for the reported product catalog number, "caution: do not withdraw catheter through needle because of the possible danger of shearing." 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 involved catheter material number.There were no other reports of this nature against the reported lot number.If additional pertinent information becomes available or if the physical sample is received for evaluation, a follow-up report will be filed.

Event Description

As reported by the user facility: reports epidural was placed; when trying to back out the catheter in laboring patient, the catheter started unraveling.At the time, a second catheter was then placed.The patient underwent surgery on (b)(6) 2015 to remove the broken catheter fragment.

• Brand Name: PERIFIX® CONTINUOUS EPIDURAL TRAYS
• 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: 5276740
• MDR Text Key: 32994452
• Report Number: 2523676-2015-00585
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: CE17TKFC
• Device Catalogue Number: 332079
• Device Lot Number: 0061454360
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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