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

Model Number ACP KIT SERIES I

Device Problems Break (1069); Fluid/Blood Leak (1250); Air/Gas in Device (4062)

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

Event Date 10/25/2022

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

On (b)(6) 2022, it was reported by a sales representative via sems that a abs-10011 acp® kits luer lock on the outer syringe was broken and caused too much air to enter the syringe during the blood draw.This occurred during an unknown case, according to the picture attached, there were signs that blood leaked.There was no patient effect reported.

Manufacturer Narrative

The complaint allegation was confirmed.Visual evaluation of the pictures attached to the complaint of an abs-10011.It was noted that blood was inside the syringe, and it is presumed that there is also air inside.The event's most likely cause(s) is a supplier manufacturing issue.

• 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: 15788208
• MDR Text Key: 307685554
• Report Number: 1220246-2022-05740
• 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,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: ACP KIT SERIES I
• Device Catalogue Number: ABS-10011
• Device Lot Number: 1197114067
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1