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

Model Number 332285

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2024

Event Type  malfunction  

Event Description

Epidural alligator clamp, intended to secure epidural catheter to epidural infusion line and maintain a sterile closed system, came disconnected.

• Brand Name: PERIFIX®
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 18939460
• MDR Text Key: 338081940
• Report Number: 18939460
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 03/06/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 108 KG
• Patient Race: White