Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE Back to Search Results
Model Number IPN028126
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/19/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box lot# 73f2000504 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 or Problem Description
It was reported that when the user loaded the clip on the applier, the clip broke (prior to use on the patient).To solve we used clips from a cartridge from the same lot number and 2 other cartridges from a different lot number with success.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEMOLOK ML CLIPS 6/CART 84/BOX
Common Device Name
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key11304787
Report Number3003898360-2021-00105
Device Sequence Number11969650
Product Code FZP
UDI-Device Identifier34026704625193
UDI-Public34026704625193
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K133202
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/22/2025
Device Model NumberIPN028126
Device Catalogue Number544230
Device Lot Number73F2000504
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/22/2021
Initial Report FDA Received Date02/09/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-