MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD ALARIS PUMP INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number (10)20013117

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2020

Event Type  malfunction  

Event Description

Iv tubing in pump noted to be "sliced" and leaking after tubing had been running for multiple hours.(no package info for this tubing).Tubing changed.Then, new tubing noted to be "blocked", and large bubble created along tubing that is in the arm of the iv pump.Second regular iv tubing set (bubble) packaging info: bd alaris pump infusion set, ref (b)(4), lot (10) 20013117, exp 01/13//2023.We recently had another issue with iv pump tubing leaking/ having a hole in the tubing with another tpn infusion.No package info for this tubing.Fda safety report id # (b)(4).

• Brand Name: BD ALARIS PUMP INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 9910045
• MDR Text Key: 186137541
• Report Number: MW5093988
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: 07613203020992
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2020

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: 01/13/2023
• Device Lot Number: (10)20013117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2020
• 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
• Patient Age: 61 YR
• Patient Weight: 54