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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC ARROW TRIPLE LUMEN CATHETER CENTRAL VENOUS CATHERIZATION KIT CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL, LLC ARROW TRIPLE LUMEN CATHETER CENTRAL VENOUS CATHERIZATION KIT CATHETER, PERCUTANEOUS Back to Search Results
Device Problems Material Frayed (1262); Stretched (1601)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/24/2021
Event Type  Malfunction  
Event Description

During the placement of an arrow central venous catheter placement, guide wire frayed and uncoiled. Resulting in the removal of the guidewire which was still intact. Then opening a new kit to use a new guidewire. Event abated after use stopped or dose reduced. Event reappeared after reintroduction: no. Fda safety report id# (b)(4).

 
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Brand NameARROW TRIPLE LUMEN CATHETER CENTRAL VENOUS CATHERIZATION KIT
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL, LLC
MDR Report Key12266562
MDR Text Key264943721
Report NumberMW5102928
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 07/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/02/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/02/2021 Patient Sequence Number: 1
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