MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER MED 6" CVD; APPLIER, SURGICAL, CLIP

Catalog Number	237061
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "that signs of water and stains were found on the label of the package during the inspection at the dealer before delivery to the hospital".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "the dhr for the returned instrument was reviewed and found complete without any irregularities.This instrument was produced at the tecomet, inc.Kenosha wi facility as part of a 100-pc.Lot in october of 2021.It was found that this order was made from the correct materials and components and all approved processes were followed.It can then be stated that the alleged non-conformance inciting this complaint was not due to an error in tecomet - kenosha's manufacturing process.Evaluation of the returned instrument/label shows that there are slight staining/water marks on the exterior surface of the label on the packaging of this device but there is additional labeling applied on top of the teleflex approved label that was provided from the tecomet, inc.Facility and the staining/water mark is also on the additional label.Further evaluation shows that the water marks/stains did not interfere with the legibility of the label as all label content remains legible and identifiable.We are able to validate this complaint for the returned instrument.We are unable to determine what caused there to be staining/water marks on the original label that was provided on this device and also on the additional label that was applied on top of the approved teleflex label, but it is suspected that this package was subjected to moisture after the additional label was applied to it and that is what caused the staining on both labels.All 100 instruments and the labeling from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed." teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported "that signs of water and stains were found on the label of the package during the inspection at the dealer before delivery to the hospital".

• Brand Name: HZ APPLIER MED 6" 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19187721
• Report Number: 3011137372-2024-00060
• Device Sequence Number: 20690869
• Product Code: GDO
• UDI-Device Identifier: 34026704622697
• UDI-Public: 34026704622697
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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 Catalogue Number: 237061
• Device Lot Number: 06B2132772
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• 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