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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 Mechanical Problem (1384); Material Separation (1562); Incomplete or Inadequate Connection (4037)
Patient Problem Insufficient Information (4580)
Event Date 04/29/2021
Event Type  malfunction  
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 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 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 Key11872446
MDR Text Key252317920
Report Number1220246-2021-03168
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 distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARTHREX ACP DOUBLE SYRINGE SYSTEM
Device Catalogue NumberABS-10010S
Device Lot Number1007109108
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/24/2021 Patient Sequence Number: 1
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