MAUDE Adverse Event Report: TELEFLEX MEDICAL VLOCK ML CLIP 6/CART 14/BOX; CLIP, IMPLANTABLE

Model Number	IPN921000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Reported as "weakness in hinge of clip".It was reported that during use on a patient, the clip broke at the hinge point when attempting to clip a vessel or duct.No report of patient harm or injury.Per the customer, it is unknown what the current status of the patient is.If further information is received, the complaint file will be updated.
Event or Problem Description
Reported as "weakness in hinge of clip".It was reported that during use on a patient, the clip broke at the hinge point when attempting to clip a vessel or duct.No report of patient harm or injury.Per the customer, it is unknown what the current status of the patient is.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.

• Brand Name: VLOCK ML CLIP 6/CART 14/BOX
• Common Device Name: CLIP, IMPLANTABLE
• 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: 16820038
• Report Number: 3011137372-2023-00114
• Device Sequence Number: 7095656
• Product Code: FZP
• UDI-Device Identifier: 14026704737434
• UDI-Public: 14026704737434
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152082
• 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): 04/12/2023

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: IPN921000
• Device Catalogue Number: 51114V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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