MAUDE Adverse Event Report: AVID MEDICAL STERILE TUPPERWARE

Model Number	LIFE0030
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that three bags had compromised seals.Tissue landed on floor because there was not a proper seal.Information received on april 23, 2026 indicated that recovered organ tissue was ultimately discarded.No specific recipient patient was identified at the time of occurrence; therefore, there was no adverse patient impact.
Additional Manufacturer Narrative
The product involved in this complaint was not available for evaluation.Avid is a convenience kit manufacturer.The complaint bag, part number 5311458, lot p645055 is supplied by degage corporation.The affected lot has been fully depleted from avid inventory.The remaining bag inventory (other lots) was inspected, and no issues were identified.In accordance with avid medical in-process inspection procedure, eight kits were inspected in accordance with ansi/asq z1.4: level g1 aql 1.5.No defects were found.A review of the bill of materials was conducted to assess whether any additional handling occurred during the assembly process; none was identified.A supplier corrective action request (scar) was issued to degage corporation on (b)(6) 2026.This product incident is documented in the complaint database and identified as complaint (b)(4).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.

• Brand Name: STERILE TUPPERWARE
• Common Device Name: STERILE TUPPERWARE
• Manufacturer (Section D): AVID MEDICAL; 9000 westmont drive; toano VA 23168
• Manufacturer (Section G): DEGAGE CORPORATION; p.o. box 1599; terrell TX 75160
• Manufacturer Contact: nichole coggins ; 9000 westmont drive; toano, VA 23168 ; 8287820529
• MDR Report Key: 25183461
• Report Number: 1047429-2026-00003
• Device Sequence Number: 10755643
• Product Code: LRO
• UDI-Device Identifier: 10809160404478
• UDI-Public: 10809160404478
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/15/2026

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: LIFE0030
• Device Catalogue Number: LIFE0030
• Device Lot Number: 1633844
• 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: 04/23/2026
• Initial Report FDA Received Date: 05/15/2026
• 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