MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER MED 11" CVD; APPLIER, SURGICAL, CLIP

Model Number	IPN914959
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported upon incoming inspection, the packaging seal was found open.No patient involvement.
Event or Problem Description
It was reported upon incoming inspection, the packaging seal was found open.No patient involvement.
Additional Manufacturer Narrative
Qn#(b)(4).One sample of product code 237111 , lot 09f2206023 , was received for evaluation in the original packaging.Close examination of the sealed edge noted that the plastic has separated along the seam line.The opening in the seam is not large enough for the instrument to be removed and all the paperwork was present in the packaging.No confirmed complaints were received in this range with the same issue.There were no issues found pertaining to incoming inspection, stock checks, and product returns.This is considered to be an isolated incident.This is a non-sterile product with no requirements for an airtight seal.Other remarks: n/a.Corrected data: n/a.

• Brand Name: HZ APPLIER MED 11" CVD
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16915912
• Report Number: 3011137372-2023-00139
• Device Sequence Number: 2161522
• Product Code: GDO
• UDI-Device Identifier: 24026704710052
• UDI-Public: 24026704710052
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN914959
• Device Catalogue Number: 237111
• Device Lot Number: 09F2206023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown