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U.S. Department of Health and Human Services

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

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ARTHREX INC. ARTHREX ANGEL BMC KIT SYRINGE, PISTON Back to Search Results
Catalog Number ABS-10062T
Device Problems Detachment Of Device Component (1104); Leak/Splash (1354); Use of Device Problem (1670)
Patient Problem No Information (3190)
Event Date 01/03/2018
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. Lot number is unknown so the device history record review cannot be performed. 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 the device is returned and additional information is obtained, a follow-up report will be submitted.
 
Event Description
It was reported by the sales rep that during a bone marrow aspirate concentrate case the angel bone marrow centrifuge tubing did not have a cap on the bottom of the red blood cell out bag so the blood ended up going everywhere at the end of the spin. The procedure was completed using the same abs-10062t. Follow-up investigation: all cases reported were bone marrow aspirate injection cases for knee osteoarthritis performed in the clinic, using the abs-10062t angel bmc kit. After the angel centrifuge was finished spinning it began to spit all the blood components back out. All the blood that was put into the "rbc out" bag was spilled out onto the counter because the port at the bottom of that section of the bag did not have a cap on it. That is not something that ever gets touched or interfered with when taking out of the kit and installing onto the centrifuge, so rep does not believe there is any way it was something the account accidentally removed or knocked off.
 
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Brand NameARTHREX ANGEL BMC 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 Key7321604
MDR Text Key101837334
Report Number1220246-2018-00082
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
Source Type company representative,distri
Reporter Occupation Medical Equipment Company Technician/Representative
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 Catalogue NumberABS-10062T
Device Lot NumberUNKNOWN
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 Received02/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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