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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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TELEFLEX INCORPORATED ARROW; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number ASK-45703-PYNH
Device Problems Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/02/2023
Event Type  malfunction  
Event Description
Upon placement of new central line, the chief resident was unable to thread the guide wire through "piner" needle.When she tried to retract the wire, it was stuck in the needle and the integrity of the guide wire was compromised.(needle capped and wire placed in [redacted name] office for review with label of packaging.Needle removed from patient, no harm to patient.New kit obtained.Residents present: [redacted name], [redacted name].Pa: [redacted name].Manufacturer response for central line, central line (per site reporter).[redacted date]: emailed arrow rep.Requested rma.[redacted date]: [redacted name] picked up the sample.
 
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Brand Name
ARROW
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
TELEFLEX INCORPORATED
3015 carrington mill blvd
morrisville NC 27560
MDR Report Key16321861
MDR Text Key309062666
Report Number16321861
Device Sequence Number1
Product Code FOZ
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 01/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberASK-45703-PYNH
Device Lot Number13F22G0594
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/30/2023
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer02/08/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/08/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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