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 VLOCK ML CLIP 6/CART 14/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 VLOCK ML CLIP 6/CART 14/BOX; CLIP, IMPLANTABLE Back to Search Results
Catalog Number 51114V
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
Doctor at (b)(6) medical center in (b)(6) mentioned at sage meeting on friday, to teleflex staff that were present, that he was having issues with the 51114v poly clips not locking consistently.The issue has already been resolved because the hospital switched from 51114v to 544240 clips recently.They switched from vessolok to hemolok.The switch took place (b)(6) 2021 at (b)(6) medical center.The facility did not keep any of the clips, that i am aware, and they did not call the rep or customer service, that i am aware.I estimated the date(s) and product amount.
 
Manufacturer Narrative
Qn# (b)(4).The finished goods dhr and the dhr's for both subassemblies used in the finished goods were reviewed.Although the lot number was not reported, a potential lot number was found through the sales history.The potential lot number is 9865.Per the dhr, lot number 9865 of product 51114v vlock ml clip 6/cart 14/box was manufactured on 22nov2019.A total of (b)(4) units were manufactured.The lot was released on 23dec2019.Dhr investigation did not show issues related to complaint.The complaint sample was not returned for investigation.Therefore, the root cause cannot be established.The complaint sample was not returned for investigation.Therefore, the root cause cannot be established.
 
Event Description
Doctor at (b)(6) medical center in (b)(6) mentioned at sage meeting on friday, to teleflex staff that were present, that he was having issues with the 51114v poly clips not locking consistently.The issue has already been resolved because the hospital switched from 51114v to 544240 clips recently.They switched from vessolok to hemolok.The switch took place (b)(6) 2021 at (b)(6) medical center.The facility did not keep any of the clips, that i am aware, and they did not call the rep or customer service, that i am aware.I estimated the date(s) and product amount.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VLOCK ML CLIP 6/CART 14/BOX
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key12018412
MDR Text Key256768138
Report Number1036844-2021-00113
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K152082
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number51114V
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-