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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. ACP KIT SERIES II SYRINGE, PISTON

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ARTHREX, INC. ACP KIT SERIES II SYRINGE, PISTON Back to Search Results
Model Number ACP KIT SERIES II
Device Problems Fluid Leak (1250); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/24/2020
Event Type  Injury  
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.
 
Event Description
In reported during an in-clinic prp injection, during blood draw the inner syringe within the abs-10012 acp kit series ii fell out. The rep reported blood leaked out of the syringe onto the floor. No individual came into contact with the blood. A second abs-10012 (lot unknown) was opened and brought in to complete the injection without further issue.
 
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Brand NameACP KIT SERIES II
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key9935143
MDR Text Key188490503
Report Number1220246-2020-01777
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK070069
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 04/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2021
Device Model NumberACP KIT SERIES II
Device Catalogue NumberABS-10012
Device Lot Number920395643
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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