MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK L CLIPS 3/CART 42/BOX; CLIP, IMPLANTABLE

Catalog Number 544243

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 04/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On investigation, one cartridge from catalog number 544243, hemolok l clips 3/cart 42/box was received.Lot #73d1800405 was confirm.During visual inspection was observed that the packaged was received damaged with a cracking on the tray.The device history review for the product hemolok l clips 3/cart 42/box lot# 73d1800405 investigation did not show issues related to the complaint.A corrective action cannot be determined since it was not possible to recreate the failure mode to determine a root cause and then can establish a proper corrective action plan.One cartridge was received damaged with a cracking on tray, due to sample conditions the failure mode "box/pouch damaged/torn" was confirmed, however, this defect is not observed during manufacturing process therefore is not possible to determine a root cause at this moment.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the customer found the package was damaged during inspection.

• Brand Name: HEMOLOK L CLIPS 3/CART 42/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: 8827830
• MDR Text Key: 153135704
• Report Number: 3003898360-2019-00980
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2023
• Device Catalogue Number: 544243
• Device Lot Number: 73D1800405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2018
• 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