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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX INC. ARTHREX ANGEL PRP KIT SYRINGE, PISTON

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ARTHREX INC. ARTHREX ANGEL PRP KIT SYRINGE, PISTON Back to Search Results
Catalog Number ABS-10061T
Device Problems Fluid Leak (1250); Component Missing (2306)
Patient Problem No Code Available (3191)
Event Date 02/01/2018
Event Type  Injury  
Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided. 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 therefore the complainant's event could not be verified. 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 that during a procedure, the customer did not notice that the angel prp kit came with no end cap on the rbc bag and spun the blood and when it was finished it pumped the rbc onto the floor. The blood was cleaned and the angel cassette and bag were disposed of. No adverse effect to the patient. Patient is a male, (b)(6).
 
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Brand NameARTHREX ANGEL PRP KIT
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 Key7302136
MDR Text Key101118642
Report Number1220246-2018-00070
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121124
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/01/2019
Device Catalogue NumberABS-10061T
Device Lot Number723576838
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 Received02/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2016
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: 02/28/2018 Patient Sequence Number: 1
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