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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE Back to Search Results
Model Number IPN915182
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2022
Event Type  malfunction  
Event Description
It was reported that a clip could not be loaded into the applier properly during use.The user opened another unit, of which could load the clips properly.No misalignement and damage was found on the jaws tip of the applier.
 
Manufacturer Narrative
Qn#(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 a clip could not be loaded into the applier properly during use.The user opened another unit, of which could load the clips properly.No misalignement and damage was found on the jaws tip of the applier.
 
Manufacturer Narrative
Qn# (b)(4).Per dhr the product hemolok ml clips 6/cart 84/box lot# 73j2100172 was manufactured on 09/07/2021 a total of (b)(4) pieces.Lot was released on 09/24/2021.Dhr investigation did not show issues related to complaint.The customer returned one cartridge with four clips remaining of 544230 hemolok ml clips 6/cart 84/box for investigation.Biological material and slight scrape marks were observed on the top of the returned cartridge.Additionally, a clip fragment was discovered on the bottom of the returned cartridge.No other defects or anomalies were observed.According to r & d, the observed damage to the clip fragment is consistent with excessive force during loading of the clip or with using damaged appliers.Reference attached file (b)(4) for investigation.Functional inspection was performed on the returned clips.A lab inventory clip applier was used.All clips were able to properly load into the jaws of the applier and were successfully applied to over-stressed surgical tubing without falling from the applier or d etaching.No functional issues were found with the returned clips.Reference the ifu for this product, l02425, was reviewed as a part of this complaint investigation.The ifu states, "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." the reported complaint of "difficulty loading clip into applier" was not confirmed based upon the samples received.Upon functional inspection, all clips were able to properly load into the jaws of a lab inventory applier and were successfully applied to over-stressed surgical tubing.R & d was consulted for this complaint, and it was determined that the observed damage to the clip fragment is consistent with excessive force during loading of the clip or with using damaged appliers.Because no functional issues were found with the returned clips, the reported issue could not be confirmed.Teleflex will continue to monitor and trend on complaints of this nature.
 
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Brand Name
HEMOLOK ML CLIPS 6/CART 84/BOX
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate 21478
MX   21478
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key15536675
MDR Text Key305506034
Report Number3003898360-2022-00559
Device Sequence Number1
Product Code FZP
UDI-Device Identifier24026704695915
UDI-Public24026704695915
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K133202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN915182
Device Catalogue Number544230
Device Lot Number73J2100172
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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