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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
Device Problems Break (1069); Fluid Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 10/20/2020
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
It was reported that during a (b)(6) 2020 prp injection procedure in the physician's office the abs-10010s (lot 0164104413) inner syringe came apart/ broke off. Blood leaked out and spilled onto the floor, chair and patient. To complete the procedure a new kit was opened. The device was discarded at time of procedure due to being covered in blood.
 
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Brand NameARTHREX ACP DOUBLE SYRINGE SYSTEM
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 Key10785992
MDR Text Key214590324
Report Number1220246-2020-02312
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 health professional,user faci
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberARTHREX ACP DOUBLE SYRINGE SYSTEM
Device Catalogue NumberABS-10010S
Device Lot Number0164104413
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/04/2020 Patient Sequence Number: 1
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