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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 Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 10/09/2019
Event Type  Injury  
Manufacturer Narrative
Complaint was not confirmed. As received, the inner plunger was disassembled from the rest of the device. No abnormality was observed, upon reassembly the device was found to function as expected with no leaks. A likely cause is loosening of the inner plunger prior to or during use.
 
Event Description
It was reported that the during a intraosseous bioplasty the acp kit, abs-10011, came apart. The nurse started to draw blood from the patient for prp hydration of dbm. The plunger was drawn back and the device fell apart in hand and on the floor. No patient harm. Additional information obtained on 11/06/2019: staff was wearing sterile gloves when drawing back on the acp syringe from a vein in the forearm during surgery. The inner plunger fell out of the syringe and landed on the floor along with all blood that had been collected. Staff put on sterile gloves and used a combination of cloths and disinfectant wipes kept in the operating room to clean up the floor. All materials used to collect the blood were disposed of in trash receptacles in the room.
 
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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 Key9363968
MDR Text Key167650081
Report Number1220246-2019-01429
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 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2021
Device Model NumberACP KIT SERIES I
Device Catalogue NumberABS-10011
Device Lot Number910792826
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/22/2019 Patient Sequence Number: 1
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