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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ACP DOUBLE SYRINGE SYSTEM; SYRINGE, PISTON
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ARTHREX, INC. ARTHREX ACP DOUBLE SYRINGE SYSTEM; SYRINGE, PISTON Back to Search Results
Model Number ARTHREX ACP DOUBLE SYRINGE SYSTEM
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 04/29/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event or Problem Description
It was reported that the abs-10010s syringe fell apart right after the spin cycle and the blood fell on the floor.It appeared that the inner string would not screw in properly and would not tighten.The product was thrown away and a new kit was opened.
 
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Brand Name
ARTHREX ACP DOUBLE SYRINGE SYSTEM
Common Device Name
SYRINGE, PISTON
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11872446
Report Number1220246-2021-03168
Device Sequence Number847589
Product Code FMF
UDI-Device Identifier00888867083790
UDI-Public00888867083790
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
BK070069
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date (Section B) 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberARTHREX ACP DOUBLE SYRINGE SYSTEM
Device Catalogue NumberABS-10010S
Device Lot Number1007109108
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/05/2021
Supplement Date Received by Manufacturer05/05/2021
Initial Report FDA Received Date05/24/2021
Supplement Report FDA Received Date09/24/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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