MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Model Number CE17TKFCPS

Device Problem Infusion or Flow Problem (2964)

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

Event Date 09/04/2018

Event Type  malfunction  

Event Description

Epidural catheter placed without incident, however, the clamp style catheter connector was not patent when the connector was clamped onto the catheter.Several more trays from the same lot were subsequently opened and the same mfg issue was present.With each the connector can easily have fluid or air pushed through it but when it is clamped (with or without a catheter present) little to no fluid or air can be pushed.

• Brand Name: PERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC. ; breinigsville PA 18031
• MDR Report Key: 7864548
• MDR Text Key: 120101205
• Report Number: MW5079698
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: CE17TKFCPS
• Device Catalogue Number: 332078
• Device Lot Number: 0061622923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 77