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

Model Number 332285

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/03/2024

Event Type  malfunction  

Event Description

Two separate epidural catheters placed and unable to be flushed, both connectors replaced but both remained unable to flush even after being removed from the patient.Manufacturer response for epidural catheter connector, b braun (per site reporter).Awaiting response.

• 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: 18939535
• MDR Text Key: 338079563
• Report Number: 18939535
• 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
• 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: 1 MO
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Race: White