MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. RATE FLOW REGULATOR IV SET V5922; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number V5922

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2023

Event Type  malfunction  

Event Description

Received call from patient stating that her tigecycline infusion is going over 15 minutes and not the 30 minutes it should be.Patient confirmed that she had previously had no issue setting the rate flow to 200ml/hr for her 100ml infusion.Patient attempted to set the set to 150ml/hr but infusion is still infusing over 15 minutes.Patient reports that the lot for the v5922 tubing is 221201l.

• Brand Name: RATE FLOW REGULATOR IV SET V5922
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 16876898
• MDR Text Key: 314740822
• Report Number: MW5117261
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 05/01/2023

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: Lay User/Patient
• Device Catalogue Number: V5922
• Device Lot Number: 221201L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White