MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX CATHETER CONNECTOR; BRAUN MELSUNGEN AG (BBMAG) ANESTHESIA CONDUCTION KIT

Model Number 8451290

Device Problem Disconnection (1171)

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

Event Date 09/13/2018

Event Type  Injury  

Event Description

Rn assessed patient and noted that the perifix catheter connector has become disconnected at the epidural site.This perifix connector had been secured using the label or cloth tape correction recommendations set forth in b braun¿s medical device correction: (b)(4).

• Brand Name: PERIFIX CATHETER CONNECTOR
• Type of Device: BRAUN MELSUNGEN AG (BBMAG) ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; allentown PA
• MDR Report Key: 7934242
• MDR Text Key: 123060794
• Report Number: MW5080348
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8451290
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 76