MAUDE Adverse Event Report: BD BD MAXGUARD EXTENSION SET (MICROBORE); SET, ADMINISTRATION, INTRAVASCULAR

Model Number ME2020

Device Problems Defective Component (2292); Obstruction of Flow (2423)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

At our hospital one of our nicu rns reported to pharmacy that the lipid tubing was occluded.When investigated by the pediatric pharmacist, it appears that the tubing has a defect near the distal end that looks like a kink but is actually an occlusion inside the tubing.The type of tubing use is bd maxguard extension set (microbore) ref me2020.Exact lot unclear, however, lots available at the time included 23019157, 22109117, 22129167, and 22129131.

• Brand Name: BD MAXGUARD EXTENSION SET (MICROBORE)
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD
• MDR Report Key: 16930178
• MDR Text Key: 315289116
• Report Number: MW5117521
• 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: 05/10/2023

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: ME2020
• Device Catalogue Number: ME2020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose