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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
Catalog Number ABS-10011
Device Problems Detachment Of Device Component (1104); Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2018
Event Type  Injury  
Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication. No additional adverse consequences have been reported from this event. This device is used for treatment. Device history record review revealed nothing relevant to this event. The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The cause of the event could not be determined from the information available and without device evaluation. The potential causes of this event are being communicated to the event reporter. If additional relevant information is received, a follow-up report will be submitted.
 
Event Description
It was reported by the facility that during a blood draw for a prp injection the bigger syringe was primed and checked and the small syringe fell-off causing the whole blood to leak out. The prp was not injected.
 
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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, adverse events
1370 creekside boulevard
naples, FL 34108-1945
8009337013
MDR Report Key7321372
MDR Text Key101960266
Report Number1220246-2018-00080
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 other,user facility
Reporter Occupation
Type of Report Initial
Report Date 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/01/2019
Device Catalogue NumberABS-10011
Device Lot Number718875528
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2017
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: 03/07/2018 Patient Sequence Number: 1
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