MAUDE Adverse Event Report: BECTON DICKINSON & CO./BECTON DICKINSON J LOOP; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 22089175

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 01/21/2023

Event Type  malfunction  

Event Description

This patient was receiving continuous medication, and the pump kept alarming occluded at patient's side.After trouble shooting multiple things, it was determined to be the j loop or bd maxzero.The second port, closest to the patient, the blue part is getting squished and is occluding the other port and not letting a slow infusion medication infuse and you can't flush that port either.This has probably been happening on our unit with various patients and their infusions.The j loop was replaced after being tested that the blue part was not blocking anything.

• Brand Name: J LOOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON & CO./BECTON DICKINSON
• MDR Report Key: 16323653
• MDR Text Key: 309264507
• Report Number: MW5114768
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/03/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 22089175
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female