MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD ALAIRS PUMP INFUSION SET BACK VALVE CHECK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2426-0500

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 01/23/2020

Event Type  malfunction  

Event Description

Impaired integrity to the fluid chamber on the iv tubing right underneath the iv spike.Did not reach patient, rn noted prior to administration.

• Brand Name: BD ALAIRS PUMP INFUSION SET BACK VALVE CHECK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 9666371
• MDR Text Key: 177883609
• Report Number: MW5092735
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/28/2020

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 Expiration Date: 03/02/2022
• Device Catalogue Number: 2426-0500
• Device Lot Number: (10)19123166
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1