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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. ACP KIT SERIES II SYRINGE, PISTON

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ARTHREX, INC. ACP KIT SERIES II SYRINGE, PISTON Back to Search Results
Model Number ACP KIT SERIES II
Device Problems Fluid Leak (1250); Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2021
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
It was reported during a knee scope procedure, three different staff members tried to draw blood using the syringes provided in the abs-10012 acp kits and two of the syringes untwisted, spilling blood everywhere. One of the syringes was drawing slow and the staff member was having difficulty pulling back, until it suddenly released pressure and the syringe was separated. The acp could not be drawn.
 
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Brand NameACP KIT SERIES II
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 Key11991218
MDR Text Key259463339
Report Number1220246-2021-03272
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 06/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberACP KIT SERIES II
Device Catalogue NumberABS-10012
Device Lot Number1033109858
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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