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

Model Number	ACP KIT SERIES I
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/2/2022, it was reported by a sales representative via sems that an abs-10011 acp kit series i had an issue, the seal was not working properly and blood was leaking.This was discovered during use with no impact to the patient.Additional information has been requested.On 09/15/2022, the sales representative stated the following information via phone: this event occurred during an unspecified procedure on (b)(6) 2022.Blood was leaking where the seal was, and the prp could not be retained.No facility staff or patient was harmed, the area was decontaminated and a new abs-10011 acp kit series i, lot number unknown, was used to complete the unspecified procedure.The facility staff and the patient are fine to date.The device was discarded.
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.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: ACP KIT SERIES I
• Common Device Name: SYRINGE, 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 Key: 15445864
• Report Number: 1220246-2022-05504
• Device Sequence Number: 4622504
• Product Code: FMF
• UDI-Device Identifier: 00888867001824
• UDI-Public: 00888867001824
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: ACP KIT SERIES I
• Device Catalogue Number: ABS-10011
• Device Lot Number: 2067120133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/19/2022
• Date Device Manufactured: 04/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown