MAUDE Adverse Event Report: TELEFLEX LLC (NADC) TITANIUM LIGATION CLIP MEDIUM BLUE; CLIP, IMPLANTABLE

Model Number 40425S

Device Problem Product Quality Problem (1506)

Patient Problem Laceration(s) (1946)

Event Date 01/26/2023

Event Type  malfunction  

Event Description

A general summary is that the physicians feel this in an inferior product.The clips fall out of the applier when trying to hand it to the physician, they can sever the vessel, and the cartridge that the clips sit in will sometimes chip and come out with the clip.In this instance, the patient's vessel was lacerated requiring repair.

• Brand Name: TITANIUM LIGATION CLIP MEDIUM BLUE
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX LLC (NADC)
• MDR Report Key: 16353102
• MDR Text Key: 309402252
• Report Number: MW5114852
• Device Sequence Number: 1
• Product Code: FZP
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40425S
• 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 Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American