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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 Blood Loss (2597)
Event Date 08/25/2020
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 on (b)(6) 2020 the abs-10011 syringe broke during use. The procedure was a prp injection in the surgeons office clinic. The delay in reporting was attributed to their difficulty in locating the correct lot number. Per the facility before starting the staff primed both syringes as instructed and then attached the butterfly needle to the syringe. As the patient was approached for a venous blood draw the needle was advanced. Once the flash of blood in the butterfly tube was visualized they slowly drew back on the red flange. As this was started the red flange/piston quickly flew back on its own leaving them unable to draw back manually. Blood slowly filled the large syringe as well as the small syringe. While the syringe was filling up, blood started to leak out from what seemed to be the large syringe stopper/seal area and was dripping out onto the staff glove. At this point they stopped the blood draw. They were still able to spin the syringe and obtain the prp to complete the procedure.
 
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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 Key10785690
MDR Text Key214597326
Report Number1220246-2020-02307
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 company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
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 Number921496032
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/26/2019
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: 11/04/2020 Patient Sequence Number: 1
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