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

Model Number REF:ME2020

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2021

Event Type  malfunction  

Event Description

When tightening the connection of the bd maxguard extension set (microbore), the piece that turns continues to turn past the point of tightening.Same thing happened with three different lot numbers.Fda safety report id# (b)(4).

• Brand Name: BD MAXGUARD EXTENSION SETS (MICROBORE)
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD
• MDR Report Key: 12540038
• MDR Text Key: 273816766
• Report Number: MW5104222
• Device Sequence Number: 1
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/23/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF:ME2020
• Device Lot Number: 20075391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• 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