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

Model Number	ACP KIT SERIES II
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2020
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 during an in-clinic prp left heel injection a quantity three abs-10012 acp kit series ii (lot: 925697165 x 1 and lot: 909492367 x 2) malfunctioned.The first syringe cracked and blood leaked outside of the syringe.The blood leaked onto the syringe, and some also leaked onto the floor and on the ma's hand as well as the patient.The facility reported the ma was wearing gloves, and all surfaces were cleaned appropriately.The facility reporter stated they have the latest user manual for proper cleaning of blood spills.A second abs-10012 was opened and right upon opening the syringe fell apart completely, prior to being used.A third abs-10012 was opened.The ma administered the needle, and while trying to take the blood up, the blood only came up the butterfly line and would not go up the syringe.The injection was not completed and the patient will be rescheduled.

• Brand Name: ACP KIT SERIES II
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9750674
• Report Number: 1220246-2020-01704
• Device Sequence Number: 2855659
• Product Code: FMF
• UDI-Device Identifier: 00888867001831
• UDI-Public: 00888867001831
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK070069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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: 08/31/2021
• Device Model Number: ACP KIT SERIES II
• Device Catalogue Number: ABS-10012
• Device Lot Number: 925697165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 02/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other