MAUDE Adverse Event Report: BECTON, DICKINSON AND CO BD ALARIS PUMP INFUSION SET-BONDED TEXIUM CLOSED MALE LUER WITH PRIMING CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 22603-B007T

Device Problem Particulates (1451)

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

Event Date 01/05/2020

Event Type  malfunction  

Event Description

There were observable particulates found in the sterile chemotherapy intravenous tubing sets.Fda safety report id # (b)(4).

• Brand Name: BD ALARIS PUMP INFUSION SET-BONDED TEXIUM CLOSED MALE LUER WITH PRIMING CAP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON, DICKINSON AND CO
• MDR Report Key: 9570545
• MDR Text Key: 174666825
• Report Number: MW5092139
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2022
• Device Catalogue Number: 22603-B007T
• Device Lot Number: (10)19096492
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 1 YR
• Patient Weight: 1