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

Model Number CE18TKCD

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/21/2015

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 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becomes lodged between rigid body structures and is stretched beyond its design capabilities; or if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Per the instructions for use (ifu) for the reported product catalog number, "do not withdraw catheter through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.All available information has been forwarded to the device manufacturer of the catheter.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports the catheter sheared while being placed.Occurred in l&d.The catheter fragment was not removed from the patient.The patient is having no symptoms.The reporting facility is unsure how long a piece was retained as the remainder of the catheter was discarded.

• Brand Name: PERIFIX® CONTINUOUS EPIDURAL TRAY
• Type of Device: PERIFIX 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: 5008044
• MDR Text Key: 24691660
• Report Number: 2523676-2015-00329
• 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
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: CE18TKCD
• Device Catalogue Number: 332211
• Device Lot Number: 0061418039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2015
• 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