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

Model Number CE18TKST

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

As reported by the user facility: reports the catheter sheared upon removal.The reporter stated that a burr could be seen on the needle.There was no pt injury.Follow-up correspondence with the reporter indicated that the catheter sheared inside the pt.Resistance was felt when attempting to remove the catheter.The reporter also indicated that the anesthesiologist did not believe that surgical intervention was necessary, but the pt was going to see someone else after discharge.The reporter has not heard anything further from the pt or anesthesiologist.

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 eval.However, the facility returned an unused, unopened tray, identifying the reported lot number (0061414467), for evaluation.The catheter from the tray was subjected to occlusion, leakage, and tensile strength testing according to our specification with acceptable results.The epidural needle and catheter from the tray were also subjected to a skiving functional test according to our specification with acceptable results.There was no cutting or skiving of the catheter.In addition, under microscopic observation, no burrs or hooks were observed on the needle.Without the actual used sample, a thorough evaluation could not be performed and no specific conclusions can be drawn.Through additional correspondence with the facility, it was indicated that resistance was felt 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rigid body structures and is stretched beyond its design capabilities; or if the catheter is with drawn or partially withdrawn through the needle, thereby shearing the catheter.Per the instructions for use (ifu) for the reported product catalog number, "do not withdraw catheter through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.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number, catheter material number, or needle material number.There were no other reports of this nature against the reported lot number.All available info has been forwarded to the device mfr of the catheter and needle.If additional pertinent info becomes available, a follow-up report will be filed.

• Brand Name: PERIFIX CONTINUOUS EPIDURAL TRAY
• Type of Device: PERIFIX EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 4809347
• MDR Text Key: 5923411
• Report Number: 2523676-2015-00203
• 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 Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: CE18TKST
• Device Catalogue Number: 332081
• Device Lot Number: 0061414467
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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