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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, HEMODIALYSIS, NON-IMPLANTED
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TELEFLEX INCORPORATED ARROW; CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
Catalog Number AK-22142-CDC
Device Problems Difficult to Insert (1316); Unraveled Material (1664); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2022
Event Type  malfunction  
Event Description
"quinton catheter being placed by experienced app.After insertion the app noted that there was only 1 dilator and not 2.When she was advancing the catheter, the wire began to unravel and unable to insert.Procedure aborted and new quinton provided and inserted.We found the other dilator when the app was wrapping up the kit.It was not packaged correctly.I have the wire and the outside package with a ref# (b)(4) for the arrowg+gard blue two lumen hemodialysis catheterization kit for high volume infusions.Lot# 13f22dd0646".Manufacturer response for catheter, arrowg+gard blue two lumen hemodialysis catheterization kit for high volume infusions (per site reporter) emailed for teleflex support.Plan is for the rep to contact and retrieve the sample.Sample picked up by rep teleflex.
 
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Brand Name
ARROW
Type of Device
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Manufacturer (Section D)
TELEFLEX INCORPORATED
3015 carrington mill blvd
morrisville NC 27560
MDR Report Key15851472
MDR Text Key304178516
Report Number15851472
Device Sequence Number1
Product Code MPB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberAK-22142-CDC
Device Lot Number13F22DD0646
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/16/2022
Event Location Hospital
Date Report to Manufacturer11/23/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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