MAUDE Adverse Event Report: GYRUS ACMI, INC. COLLECTION SET TUBING PVC (10/PK); COLLECTION SET, DISPOSABLE

Model Number	23116
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the disposable collection set tubing was received repackaged and damaged.The issue occurred during receipt inspection.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacture's final investigation.Correction to the initial medwatch.The aware date should be mar 11, 2024.Correction to the initial medwatch.The aware date should be mar 11, 2024.The customer's allegation was confirmed.The device was returned and evaluation revealed damages at every layer of packaging was found.Based on the results of the investigation, it is likely that the following led to the malfunction: the damage was likely caused from shipping/handling during transportation.A device history review revealed that this device was built to specifications without any reported rework or non-conformances.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: COLLECTION SET TUBING PVC (10/PK)
• Common Device Name: COLLECTION SET, DISPOSABLE
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19124378
• Report Number: 3011050570-2024-00132
• Device Sequence Number: 7722537
• Product Code: HHI
• UDI-Device Identifier: 00821925030954
• UDI-Public: 00821925030954
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K030935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2024

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: 23116
• Device Lot Number: S230078319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 05/08/2024; 12/04/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 05/24/2024; 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown