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U.S. Department of Health and Human Services

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

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ARTHREX, INC. ACP KIT SERIES I SYRINGE, PISTON Back to Search Results
Model Number ACP KIT SERIES I
Device Problems Break (1069); Fluid Leak (1250)
Patient Problem Exposure to Body Fluids (1745)
Event Date 04/02/2020
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 syringe¿s seal on the abs-10011, acp kit series i was not working properly and it was leaking so another kit had to be opened. Additional information has been requested. Additional information received on 4/24/2020: the rep reported the malfunction occurred during an inclinc acp injection for oa. The issue occurred during the preparation portion of the case, while separating the plasma from the rest of the blood. It was reported that blood did leak outside of the syringe, and came into contact with the nurse. The device and surfaces were cleaned using disinfecting wipes. The device was discarded, and a second abs-10011 was opened and blood draw was done again. The sales rep reported that the facility does have the latest user manual for appropriate cleaning of blood spills.
 
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Brand NameACP KIT SERIES I
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 Key10055675
MDR Text Key191536765
Report Number1220246-2020-01836
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 Administrator/Supervisor
Type of Report Initial
Report Date 05/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2021
Device Model NumberACP KIT SERIES I
Device Catalogue NumberABS-10011
Device Lot Number920695773
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/19/2019
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: 05/14/2020 Patient Sequence Number: 1
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