MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX®; CATHETER, CONDUCTION, ANESTHETIC

Model Number 332285

Patient Problem Pain (1994)

Event Date 02/18/2024

Event Type  malfunction  

Event Description

On thee separate occasions, patients in obstetrics (ob) had epidurals placed for pain control.The catheter placement was done by certified registered nurse anesthetist (crna) and was routine.An alligator clip was used on the end of the catheter and secured with two additional pieces of tape to prevent it from coming displaced as recommended by b braun representative (this is a known issue).Despite adequate placement and securement of both the epidural catheter to the patient and the alligator clip to the epidural catheter, the rn called anesthesia at the time of catheter removal and noted the epidural catheter had pulled out of the alligator clip.The distal tip of the catheter was open to air.Manufacturer response for epidural catheter connector, b braun (per site reporter) b braun representative recommended taping device to catheter.This was ineffective.

• Brand Name: PERIFIX®
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th avenue; bethelehem PA 18018
• MDR Report Key: 18885194
• MDR Text Key: 337426047
• Report Number: 18885194
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 332285
• Device Catalogue Number: 332285
• Device Lot Number: 61903107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Race: Black Or African American