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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERIPHERAL CATHETER INSERTION KIT 20G X 2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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PERIPHERAL CATHETER INSERTION KIT 20G X 2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number AC0202252
Device Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 08/26/2021
Event Type  malfunction  
Event Description
Rn was inserting an accucath and had trouble threading the catheter. When rn removed the device and retracted the needle, the guidewire had a plastic piece of the catheter stuck to it and was filled with blood. This did not result in a retained foreign body. No harm to the patient. Manufacturer response for catheter,intravascular,therapeutic,short-term less than 30 days, peripheral catheter insertion kit. Awaiting response.
 
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Brand NamePERIPHERAL CATHETER INSERTION KIT 20G X 2.25
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12420949
MDR Text Key269771796
Report Number12420949
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAC0202252
Device Catalogue NumberAC0202252
Device Lot NumberREFQ1165
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/30/2021
Event Location Hospital
Date Report to Manufacturer09/03/2021
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 Unkown

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