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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 Leak/Splash (1354); Separation Problem (4043)
Patient Problem Insufficient Information (4580)
Event Date 12/17/2021
Event Type  malfunction  
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. If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
On (b)(6) 2021, it was reported by a sales representative via email that an abs-10011 acp kit had the inner syringe pop out during the blood draw, even after it was tightened. This was discovered during a procedure. Additional information received 12/23/2021: this occurred during a knee injection procedure and surgeon completed case using another abs-10011 kit from the same lot number without further issues. Additional information received 12/23/2021: during the blood draw, the inner syringe popped out and caused a leak.
 
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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 Key13154455
MDR Text Key285610805
Report Number1220246-2022-04239
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 Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 01/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberACP KIT SERIES I
Device Catalogue NumberABS-10011
Device Lot Number1197114067
Was Device Available for Evaluation? No
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/10/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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