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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 Fluid Leak (1250); Explosion (4006)
Patient Problem Exposure to Body Fluids (1745)
Event Date 06/15/2020
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 the blood draw was being done using an abs-10010s, acp double syringe system. The kit exploded over the doctor, patient and the room. It was cleaned up and the doctor repeated the process. (b)(6) year old patient. Additional information obtained 6/18/2020: when the surgeon was conducting the procedure the inner syringe plunger was pushed out from the pressure inside and the patient's blood went all over the room. It was on the floor, walls, the surgeon's clothing, shoes, and on the patient as well. The office had to complete the procedure using another kit. The room was then closed for the remainder of the day while the blood spill was cleaned per blood borne pathogen cleaning process. The device was discarded due to blood exposure.
 
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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 Key10217789
MDR Text Key197300802
Report Number1220246-2020-01933
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
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 Model NumberARTHREX ACP DOUBLE SYRINGE SYSTEM
Device Catalogue NumberABS-10010S
Device Lot Number918695225
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2019
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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