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

Model Number IPN915182

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box ,lot# 73j2000826 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

We have a hem-o-lok 1ea that has a piece of tape/paper that is sealed within the package and outside the package, but it is not a complete seal so this item is considered contaminated and is not able to be used in surgery, we would like a credit for the 1ea.

Event Description

We have a hem-o-lok 1ea that has a piece of tape/paper that is sealed within the package and outside the package, but it is not a complete seal so this item is considered contaminated and is not able to be used in surgery, we would like a credit for the 1ea.

Manufacturer Narrative

(b)(4).The customer returned one unit 544230 hemolok ml clips 6/cart 84/box for investigation.The sample was returned closed in its original packaging.The returned sample was visually examined with and without magnification.Upon visual examination, it was observed that a piece of paper was sealed in the package with the sample.The piece of paper goes through the sterile barrier.Re-003020 was opened to further investigate this issue.The risk evaluation determined that the risk is low and that no further actions are required.We will continue to monitor and trend on this issue.The reported complaint of "foreign material - paper in package" was confirmed based on the returned sample.The sample was returned with a piece of paper going through the sterile barrier of the sealed package.This is a manufacturing related issue.Re-003020 was opened by the manufacturing site.The risk evaluation determined that the risk is low and that no further actions are required.We will continue to monitor and trend on this issue.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12187605
• MDR Text Key: 262154810
• Report Number: 3003898360-2021-00620
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 73J2000826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1