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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM

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TELEFLEX INCORPORATED ARROW CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM Back to Search Results
Model Number CDC-42802XP1A
Device Problems Difficult to Remove (1528); Unraveled Material (1664)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2020
Event Type  malfunction  
Event Description
During placement of a left subclavian central line by a surgeon, when the guide wire was pulled out after placing the catheter, it was difficult to remove. When removed, the wire was found to be frayed/unraveled. A new guide wire was used to ensure correct placement of the catheter and a chest x-ray was taken to look for any part of the guide wire that may have been retained. Per the radiologist, "no metallic radiopaque foreign body identified". Packaging and wire given to manager and sequestered.
 
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Brand NameARROW
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key9877349
MDR Text Key184847542
Report Number9877349
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 Risk Manager
Type of Report Initial
Report Date 02/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCDC-42802XP1A
Device Lot Number23F19J008
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/20/2020
Event Location No Information
Date Report to Manufacturer03/25/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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