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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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ARROW INTERNATIONAL, LLC CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number CDC-45703-XP1A
Device Problems Material Deformation (2976); Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 03/18/2022
Event Type  malfunction  
Event Description
Central line guidewire unfurled during the procedure inside the patient.
 
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Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
ARROW INTERNATIONAL, LLC
po box 12600
durham NC 27709
MDR Report Key14235549
MDR Text Key290275781
Report Number14235549
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
Type of Report Initial
Report Date 04/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberCDC-45703-XP1A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/26/2022
Date Report to Manufacturer04/28/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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