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	01/23/2019
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 devices were reported to have been discarded.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 a quantity of two abs-10012, acp kit series ii from lot 820785151 leaked outside of the syringe during an in-clinic procedure.The issue occurred during blood draw, and both the patient and staff came into contact with the blood.The exposed blood was cleaned with paper towels and (b)(6) wipes.The blood draw was being taken from the antecubital fossa.The facility took pictures of the kits, and then discarded into the appropriate disposal bin.The account confirmed that they have the latest user manual for the appropriate cleaning of blood spills.The account stated it is unknown what caused the devices to leak, and there were not any noticeable damages or deformities with either of the kits.

• 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: 8344421
• Report Number: 1220246-2019-00899
• Device Sequence Number: 1734644
• Product Code: FMF
• UDI-Device Identifier: 00888867001831
• UDI-Public: 00888867001831
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK070069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

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: 04/30/2020
• Device Model Number: ACP KIT SERIES II
• Device Catalogue Number: ABS-10012
• Device Lot Number: 820785151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/15/2019
• 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