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

Model Number	ACP KIT SERIES II
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/14/2022, it was reported by a sales representative via email that an acp kit series ii had an issue, the seal in one of the syringes was defective and leaked when drawing blood.This was discovered during use with no impact to the patient.On 06/22/2022, the sales representative replied via email and stated the following information: this event occurred during an unspecified procedure on (b)(6) 2022.No anti-coagulant was used and no air bubbles were observed during the blood draw.They opened another kit and it worked fine, the case was completed.The patient is fine to date.
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 II
• 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: 14914714
• Report Number: 1220246-2022-05166
• Device Sequence Number: 16641739
• 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: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/05/2022

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 Model Number: ACP KIT SERIES II
• Device Catalogue Number: ABS-10012
• Device Lot Number: 1049110286
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 07/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown