MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. IV DISPOSABLE TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 00VL836624

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 09/30/2022

Event Type  malfunction  

Event Description

Tubing was manufactured with parts applied upside down and were unable to be loaded into the pump housing.Green clamp was also applied upside down, hook does not fit in pump.Fda safety report id# (b)(4).

• Brand Name: IV DISPOSABLE TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 15754396
• MDR Text Key: 303330572
• Report Number: MW5113133
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/03/2022

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 Lot Number: 00VL836624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other