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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. ACCUCATH CATHETER THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS, INC. ACCUCATH CATHETER THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number AC0182250
Device Problems Retraction Problem (1536); Failure to Advance (2524)
Patient Problem Insufficient Information (4580)
Event Date 09/25/2020
Event Type  malfunction  
Event Description
In radiology bay 12 i was called to place an 18g in the rac. I had to use ultrasound. My first attempt failed and so with my second attempt i used an 18g accucath. Before insertion i checked the guidewire and it functioned properly. During insertion i visualized the tip of the needle in the vessel and then when i tried to advance the guidewire it would not advance at all, it just would not even budge. So i tried just advancing the catheter without the guidewire, and it slid in and blood began to come out around the needle. When i pressed the button to retract the needle it did not retract at all. I removed the needle from the catheter slowly and again there was some blood coming out. I then thought i was in the vein with a successful iv and connected the extension set with an empty 3cc syringe on it to obtain a blood sample. I was not able to draw back any blood at all. I attempted a few times without success, so then i removed the 3cc syringe and connected a flush and the catheter would not flush at all. I removed the catheter expecting to see a kink or something to explain this but there was nothing wrong with the catheter. Even after it was removed from the patient i was not able to flush it. I believe the accucath and the extension set both malfunctioned. Fda safety report id# (b)(4).
 
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Brand NameACCUCATH CATHETER
Type of DeviceTHERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
salt lake city UT
MDR Report Key10697303
MDR Text Key212109222
Report NumberMW5097286
Device Sequence Number1
Product Code FOZ
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 10/14/2020
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received10/16/2020
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue NumberAC0182250
Device Lot NumberREEN1049
Was Device Available for Evaluation? Yes
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

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