MAUDE Adverse Event Report: B. BRAUN PERIFIX FX

Model Number 332097

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

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

Event Date 04/13/2018

Event Type  Injury  

Event Description

While placing epidural, 3/4cm of tip of catheter broke off and was unaccounted for.

• Brand Name: PERIFIX FX
• Type of Device: PERIFIX FX
• Manufacturer (Section D): B. BRAUN; bethlehem PA 18018
• MDR Report Key: 7457643
• MDR Text Key: 106700914
• Report Number: MW5076685
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 332097
• Device Catalogue Number: CE17TKFCS
• Device Lot Number: 0061588414
• Was Device Available for Evaluation?: Yes
• 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 Outcome(s): Hospitalization
• Patient Age: 33 YR