MAUDE Adverse Event Report: BECTON DICKINSON / CAREFUSION 303, INC. BD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 30914

Device Problem Defective Device (2588)

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

Event Date 11/18/2022

Event Type  malfunction  

Event Description

Luer lock end of extension tubing defective.Would not tighten to form a closed system.Allowed air to enter line.Fda safety report id #(b)(4).

• Brand Name: BD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON / CAREFUSION 303, INC.
• MDR Report Key: 15855581
• MDR Text Key: 304332516
• Report Number: MW5113445
• 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: 11/18/2022

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 Model Number: 30914
• Device Catalogue Number: 30914
• Device Lot Number: (10)22089342
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose