MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX®; ANESTHESIA CONDUCTION KIT

Model Number CE17TKFCS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.However, the facility did send photos of the involved catheter.Based on the photos, the catheter appeared to be fractured / sheared near the tip end, with the inner coil unwound and stretched out at the area of the break.However, no specific conclusions can be drawn from the photos.It was indicated in the event summary that the catheter was removed through the needle.Incidents of this nature can occur if the catheter is withdrawn or partially withdrawn through the needle, thereby shearing the catheter.Per the instructions for use (ifu) for the reported product catalog number, "do not withdraw catheter through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.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 # mw5065645: "epidural catheter was inserted at l3-4 and threaded to 8 cm, then became stuck.While attempting to remove the catheter through the needle, the catheter broke while still inside of the pt.The catheter tip was successfully retrieved.".

• Brand Name: PERIFIX®
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: bridseida melendez ; 901 marcon blvd; allentown, PA 18109 ; 6102660500
• MDR Report Key: 6118103
• MDR Text Key: 60620706
• Report Number: 2523676-2016-00805
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 04046964177361
• UDI-Public: (01)04046964177361(17)171231(10)0061502019
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/31/2017
• Device Model Number: CE17TKFCS
• Device Catalogue Number: 332097
• Device Lot Number: 0061502019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2016
• 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
• Patient Outcome(s): Required Intervention