MAUDE Adverse Event Report: LEICA BIOSYSTEMS RICHMOND INC. ACTIVFLO ROUTINE I-TAPED-YELLOW 1000; CASSETTES, TISSUE

Model Number	ACTIVFLO ROUTINE I-TAPED-YELLOW 1000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported activflo routine i-taped-yellow 1000, p/n 39lc-500-9-l, lot 20240716 was popping open.The small plastic locking pieces on the front of the cassette are weaker than usual and have been breaking or not strong enough to lock properly.No adverse events were reported.Trending analysis from 26 jun 2024 to 26 jun 2025 reported one (1) other related occurrence of this issue for this product lot.The product history was reviewed and did not identify information in the manufacturing record for this product that could have caused or contributed to the problem reported in this complaint.Manufacturer testing of retain samples was unable to replicate the "yellow cassettes aren¿t staying closed" reported by the customer.The root cause for the "yellow cassettes aren¿t staying closed" reported by the customer could not be unequivocally determined from the information available.If additional information is received a follow up mdr will be submitted.
Event or Problem Description
On 23 june 2025, leica biosystems received the following information: "yellow cassettes aren¿t staying closed.They keep popping open on them.About 15% of the cassettes are having issues." no adverse consequence(s) to a patient(s) has been reported to the manufacturer to date.

• Brand Name: ACTIVFLO ROUTINE I-TAPED-YELLOW 1000
• Common Device Name: CASSETTES, TISSUE
• Manufacturer (Section D): LEICA BIOSYSTEMS RICHMOND INC.; 5205 us-12; richmond IL 60071
• Manufacturer (Section G): XIAMEN VOKE MOLD & PLASTIC ENGINEER; no. 1152-1160 and no.1166-117; chun guang rd,; xiamen city, fujian province 00003 6110; CH 0000361101
• Manufacturer Contact: heather jensen ; 5205 us-12; richmond, IL 60071 ; 8152988371
• MDR Report Key: 22572837
• Report Number: 1419341-2025-00031
• Device Sequence Number: 9637611
• Product Code: IDZ
• UDI-Device Identifier: 20849832022446
• UDI-Public: 20849832022446
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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: ACTIVFLO ROUTINE I-TAPED-YELLOW 1000
• Device Catalogue Number: 39LC-500-9-L
• Device Lot Number: 20240716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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