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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 Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2016
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 the inner seal of the abs10010s (lot 715674659) was not sealed correctly and prp leaked. Additional information obtained 6/25/20: the procedure took place sometime in 2016 at the surgeons office. The procedure was an ankle injection. The leakage did contain bodily fluid and the fluid leaked onto/from the tip of the syringe. The device was disposed of at the time of procedure. Specific date of procedure in 2016 is unknown. (b)(6) 2016 will be entered as a date of occurrence.
 
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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 Key10218377
MDR Text Key197211693
Report Number1220246-2020-01942
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
BK070069
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 07/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2021
Device Model NumberARTHREX ACP DOUBLE SYRINGE SYSTEM
Device Catalogue NumberABS-10010S
Device Lot Number715674659
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/19/2017
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: 07/01/2020 Patient Sequence Number: 1
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