MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE

Catalog Number 544230

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box lot# 73e1800633 investigation did not show issues related to complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during incoming inspection there was loose clips in the package and the sterile package was not sealed.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 8511049
• MDR Text Key: 141817832
• Report Number: 3003898360-2019-00391
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/26/2019

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 Expiration Date: 05/22/2023
• Device Catalogue Number: 544230
• Device Lot Number: 73E1800633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1