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

Lot Number 61836363

Device Problems Failure to Prime (1492); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2022

Event Description

Iv tubing unable to be primed due to tubing defect.Fda safety report id# (b)(4).

• Brand Name: DISPOSABLE IV TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 15754055
• MDR Text Key: 303335423
• Report Number: MW5113123
• 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?: No
• Device Operator: Health Professional
• Device Lot Number: 61836363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• 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