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

Model Number ACP KIT SERIES I

Device Problems Leak/Splash (1354); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

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.

Event Description

It was reported that during a blood drawn into the acp double syringe.The butterfly needle was removed from the syringe and discarded into the sharps bin.The red cap was fastened onto the acp double syringe.The red cap would not advance tightly onto the double syringe.There was some blood coming out of the cap.The staff tried to tighten the cap again but this time uses a hemostat.The cap still would not advance.They wrapped the syringe in gauze and placed it into the centrifuge.Most of the blood leaked out during the spin process.They discarded the syringe with the remaining blood into the biohazard.They opened a new kit and proceeded without any issues.They did not alternate the treatment in anyway aside from needing to open a new kit.The patient was not effected by this issue in anyway.The double syringe was discarded in the biohazard bin and is not available for return.

• Brand Name: ACP KIT SERIES I
• Type of Device: 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: 12121950
• MDR Text Key: 262517107
• Report Number: 1220246-2021-03349
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00888867001824
• UDI-Public: 00888867001824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK070069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: ACP KIT SERIES I
• Device Catalogue Number: ABS-10011
• Device Lot Number: 0288107125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2021
• Date Device Manufactured: 12/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1