MAUDE Adverse Event Report: AVID MEDICAL, INC. LIFE01- ORGAN RECOVERY OR PACK; LIFE01 - ORGAN RECOVERY OR PACK

Model Number	LLOF1000-17
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.Avid medical is a convenience kit manufacturer.The complaint component (part number 520319) is supplied by (b)(4) a supplier corrective action request was issued to the component distributor on (b)(6) 2025.The supplier has advised that the bag is manufactured by berry global inc.And not suitable for medical purposes.The root cause of the nonconformance was the inclusion of a non-medical component in a medical device convenience kit.This failure resulted from inadequate identification and documentation of design inputs, which led to the introduction of a component that does not meet the required medical standards.A corrective and preventive action (capa) has been initiated to conduct a thorough investigation into the root cause of this issue.The capa will focus on enhancing design input controls and implementing robust process measures to prevent the recurrence of similar nonconformities, ensuring that only compliant, medical-grade components are included in future medical device kits.The complaint bag has been removed from this kit and quoting is working with customer to replace with an alternate bag/container which is approved for medical storage and transportation.This product incident is documented in the complaint database and identified as complaint (b)(6).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or caused serious injury.
Event or Problem Description
During an organ recovery procedure, it was discovered that the plastic bag contained within the avid organ recovery pack was not properly sealed.Specifically, the bottom of the bag lacked a proper seal.A recovered liver fell through the bag and landed on floor.There was no adverse impact to the donor or organ.The organ was used by the intended recipient.

• Brand Name: LIFE01- ORGAN RECOVERY OR PACK
• Common Device Name: LIFE01 - ORGAN RECOVERY OR PACK
• Manufacturer (Section D): AVID MEDICAL, INC.; 9000 westmont drive; toano VA 23168
• Manufacturer (Section G): CANTWELL-CLEARY CO.; 7575 washington blvd; elkridge MD 21075
• Manufacturer Contact: nichole coggins ; 9000 westmont drive; toano, VA 23168 ; 8287820529
• MDR Report Key: 23291039
• Report Number: 1047429-2025-00004
• Device Sequence Number: 14658636
• Product Code: LRO
• UDI-Device Identifier: 10809160258095
• UDI-Public: 10809160258095
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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: LLOF1000-17
• Device Catalogue Number: LLOF1000-17
• Device Lot Number: 1651709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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