MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-RTI RECOVERY PACK

Catalog Number	DYNJ85775A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024, during a "tissue recovery" the bag that was used for "packaging of tissue" caused the "contents to spill out" because the "heat seal gave out".The customer reported the tissue was "discarded" due to the reported incident.The customer reported there was no serious injury, medical intervention, or follow-up care related to the reported incident.No additional information is available.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on (b)(6) 2024, during a "tissue recovery" the bag that was used for "packaging of tissue" caused the "contents to spill out" because the "heat seal gave out".

• Common Device Name: DBD-RTI RECOVERY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21284314
• Report Number: 1423395-2025-00008
• Device Sequence Number: 9319999
• Product Code: LRO
• UDI-Device Identifier: 40195327622924
• UDI-Public: 40195327622924
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: DYNJ85775A
• Device Lot Number: 24IBM242
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown