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

Model Number	ACP KIT SERIES I
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the second syringe dropped out of the double syringe without any twisting or pressure following a blood draw, resulting in spillage of specimen fluid.No further information provided.Further information requested.Additional information obtained 6/16/2020: procedure was a blood draw and prp injection.The procedure was performed in the surgeon's office.The spillage of specimen fluid was cleaned with sani-wipes and disinfectant.The specimen fluid came in contact with the mid-level provider who was using the device, only on clothing and arms.Provider was wearing gloves/ppe.The facility has provided a lot number (930598580) which does not match the part number provided (abs-1001) with the original report.It has been determined that the correct part number is abs-10011.

• Brand Name: ACP KIT SERIES I
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10217837
• Report Number: 1220246-2020-01934
• Device Sequence Number: 2120938
• Product Code: FMF
• UDI-Device Identifier: 00888867001817
• UDI-Public: 00888867001817
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: BK070069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: ACP KIT SERIES I
• Device Catalogue Number: ABS-10011
• Device Lot Number: 930598580
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other