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 05/27/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device history review for hemolok ml clips 6/cart 84/box lot# 73k2100706 investigation did not show issues related to the complaint.

Event Description

(b)(6) 2022, packaging was not sealed during incoming inspection.

Event Description

(b)(6) 2022, packaging was not sealed during incoming inspection.

Manufacturer Narrative

Qn#(b)(4) the customer provided one photo for analysis; reference pic 1_tc#(b)(4),tc#(b)(4) for the customer supplied photo.The complaint of "incomplete seal - sterility compromised" was able to be confirmed by the photo.The customer returned one unit of 544230 hemolok ml clips 6/cart 84/box.The sample was returned partially opened in its original packaging.Upon visual examination, there was no evidence of the sterile barrier seal on the part of the packaging that was opened.A non-conformance has been opened to further investigate this issue.The root cause of this complaint is packaging related.A non-conformance has been opened to further investigate this issue.The root cause of this complaint is packaging related.The reported complaint of "incomplete seal - sterility compromised" was confirmed based upon the sample received.The sample was returned partially opened in its original packaging.Upon visual examination, there was no evidence of the sterile barrier seal on the part of the packaging that was opened.A non-conformance has been opened to further investigate this issue.The root cause of this complaint is packaging related.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: 14676809
• MDR Text Key: 301247417
• Report Number: 3003898360-2022-00229
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• 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: Foreign,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• 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: 73K2100706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• 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