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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); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2021
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 the syringe loosened from the kit, causing blood leakage. There was no contamination on the patient or staff.
 
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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 Key11724535
MDR Text Key247291105
Report Number1220246-2021-02944
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 health professional,user faci
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberACP KIT SERIES I
Device Catalogue NumberABS-10011
Device Lot Number0149104063
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/02/2020
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: 04/26/2021 Patient Sequence Number: 1
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