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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 04/04/2022

Event Type  malfunction  

Event Description

When setting up a primary line for a patient, it was noted that the space pump tubing was manufactured backwards.Had it been connected to the patient, the line would have pulled blood out of the patient and brought it up into the fluid bag.Fda safety report id # (b)(4).

• Brand Name: TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 14074487
• MDR Text Key: 289100539
• Report Number: MW5108869
• 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: 04/06/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1