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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK L CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL HEMOLOK L CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE Back to Search Results
Catalog Number 544240
Device Problems Leak/Splash (1354); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the clip slipped off from the applier during usage on the patient.It was caused by the applier which has been used for a long time and its jaw was found misaligned.Then changing a new clip and it worked.No clip fell into the patient.The condition of the patient was fine.
 
Manufacturer Narrative
Qn#(b)(4).Per dhr the product hemolok l clips 6/cart 84/box lot# 73a1800738 was manufactured on 01/28/2018 a total of (b)(4) pieces.Lot was released on 02/02/2018.Dhr investigation did not show issues related to complaint.Revision of fmea-08-025 rev 05 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
 
Event Description
It was reported that the clip slipped off from the applier during usage on the patient.It was caused by the applier which has been used for a long time and its jaw was found misaligned.Then changing a new clip and it worked.No clip fell into the patient.The condition of the patient was fine.
 
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Brand Name
HEMOLOK L CLIPS 6/CART 84/BOX
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9340970
MDR Text Key170730234
Report Number3003898360-2019-01346
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K133202
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 10/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/28/2023
Device Catalogue Number544240
Device Lot Number73A1800738
Was Device Available for Evaluation? No
Date Manufacturer Received11/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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