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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOCLIP TI SMALL 10CART 240/BOX; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL HEMOCLIP TI SMALL 10CART 240/BOX; CLIP, IMPLANTABLE Back to Search Results
Catalog Number 523835
Device Problem Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product hemoclip ti small 10cart 240/box lot #73g1700100 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that clips were falling from applier during use.
 
Manufacturer Narrative
Qn#(b)(4).Report 3003898360-2019-01037 is retracted.The preliminary investigation of the returned device sample shows clips loosened from an unopened cartridge and there was no patient involvement.Report 3003898360-2019-01037 is retracted base on this new information.
 
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Brand Name
HEMOCLIP TI SMALL 10CART 240/BOX
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8920860
MDR Text Key155206511
Report Number3003898360-2019-01037
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K132658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 08/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/04/2022
Device Catalogue Number523835
Device Lot Number73G1700100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2019
Date Manufacturer Received08/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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