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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL VLOCK ML CLIP 6/CART 14/BOX; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL VLOCK ML CLIP 6/CART 14/BOX; CLIP, IMPLANTABLE Back to Search Results
Model Number IPN921000
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2023
Event Type  malfunction  
Event Description
It was reported that while in use on a patient during the clipping of an artery, the clip would not clip into the secured position.As a result, a 2nd package was opened and used and the same event occurred.The issue was resolved by using device from a different brand.No patient harm or injury.See associated mdr #3011137372-2023-00182.
 
Manufacturer Narrative
Qn#(b)(4).
 
Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and 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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Other remarks: n/a corrected data: n/a.
 
Event Description
It was reported that while in use on a patient during the clipping of an artery, the clip would not clip into the secured position.As a result, a 2nd package was opened and used and the same event occurred.The issue was resolved by using device from a different brand.No patient harm or injury.See associated mdr #3011137372-2023-00182.
 
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Brand Name
VLOCK ML CLIP 6/CART 14/BOX
Type of Device
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 Key17309518
MDR Text Key318895982
Report Number3011137372-2023-00191
Device Sequence Number1
Product Code FZP
UDI-Device Identifier14026704737434
UDI-Public14026704737434
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K152082
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN921000
Device Catalogue Number51114V
Device Lot Number228147
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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