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

Model Number IPN915184

Device Problem Unsealed Device Packaging (1444)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

Reported issue: the clips are poorly packed and open.Found prior to use.

Manufacturer Narrative

Qn#(b)(4).P/n 544240 is not being manufactured currently, however, another part number from the same family was use for the verification of failure mode reported in the current manufacturing process and during the test issue reported incomplete seal - sterility compromised was not observed in the current manufacturing process.The device history review for the product hemolok l clips 6/cart 84/box lot# 73d2200552 investigation did not show issues related to the complaint.The customer complaint cannot be confirmed and corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation, confirm the alleged defect and determine the root cause.At this time due the sample is not available is not possible to determine the source of the defect reported.

• Brand Name: HEMOLOK L 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15987939
• MDR Text Key: 306731504
• Report Number: 3003898360-2022-00864
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 44026704695933
• UDI-Public: 24026704695939
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K133202
• 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
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915184
• Device Catalogue Number: 544240
• Device Lot Number: 73D2200552
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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
• Treatment: NONE REPORTED