MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. BLOOD TUBING SET; IV ADMINISTRATION SETS

Lot Number 0061804145

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/12/2022

Event Type  Injury  

Event Description

Tubing broke at connection of distal y site at anti siphon valve.Blood dripping from same during transfusion.Fda safety report id # (b)(4).

• Brand Name: BLOOD TUBING SET
• Type of Device: IV ADMINISTRATION SETS
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 14136914
• MDR Text Key: 289538183
• Report Number: MW5109073
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0061804145
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR