MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER SMALL 11" CVD; INSTRUMENTS, SURGICAL, CARDIO

Catalog Number 137111

Device Problem Mechanics Altered (2984)

Patient Problem Insufficient Information (4580)

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Reported as "ligation failure".No other information was provided.At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

Event Description

Reported as "ligation failure".No other information was provided.At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.All the devices from this lot were 100% visually inspected and function tested prior to shipment to the customer.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: HZ APPLIER SMALL 11" CVD
• Type of Device: INSTRUMENTS, SURGICAL, CARDIO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17540637
• MDR Text Key: 321148662
• Report Number: 3011137372-2023-00206
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 34026704622659
• UDI-Public: 34026704622659
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

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 Catalogue Number: 137111
• Device Lot Number: 06E1869933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1