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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 Fluid Leak (1250); Device Fell (4014)
Patient Problems Exposure to Body Fluids (1745); Blood Loss (2597)
Event Date 07/08/2020
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 prp injection, after the acp kit, abs-10011, was removed from the kit, checked and tightened before withdrawing the blood from the patient. While blood was being drawn, the inner syringe fell out causing the facility to loose the 15cc of blood. Another abs-10011 was opened and the procedure was completed. Additional information provided on 07/13/2020: the customer stated that ¿the blood along with the inner syringe fell on the floor causing blood to also spill onto the customer's glove. Customer removed gloves appropriately. An enzymatic cleaner was used to clean the floor. Blood got onto the surgeon forearm, both individuals scrubbed with betadine and finished with avaguard¿.
 
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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 Key10332107
MDR Text Key200773362
Report Number1220246-2020-01972
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJM
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 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2021
Device Model NumberACP KIT SERIES I
Device Catalogue NumberABS-10011
Device Lot Number930598580
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/04/2019
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: 07/28/2020 Patient Sequence Number: 1
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