MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. FILTERED EXTENSION SET 0.2; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 354221

Device Problems Crack (1135); Gas/Air Leak (2946)

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

Event Date 07/09/2019

Event Type  malfunction  

Event Description

White filtered extension set cracked causing air to enter into pt's umbilical venous line, and blood to back up from the pt's umbilical vein.Filter crack required central line to be accessed and broken into with 2 rns to replace the filter and remedy the situation.

• Brand Name: FILTERED EXTENSION SET 0.2
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 8803105
• MDR Text Key: 151613149
• Report Number: MW5088213
• Device Sequence Number: 1
• Product Code: FPA
• 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: 07/11/2019

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 Operator: Health Professional
• Device Model Number: 354221
• Device Catalogue Number: 354221
• Device Lot Number: 0061674956
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2019
• 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