MAUDE Adverse Event Report: XIAMEN VOKE MOLD & PLASTIC ENGINEER ACTIVFLO ROUTINE I-TAPED- BLUE 1000; CASSETTES, TISSUE

Model Number	ACTIVFLO ROUTINE I-TAPED- BLUE 1000
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported activflo routine i-taped- blue 1000, p/n 39lc-500-2-l, lot 20250307 seemed quite flimsy, and staff have had issues with them closing properly.No adverse events were reported.Trending analysis from 15 oct 2024 to 15 oct 2025 reported no (0) other related occurrences of this issue for this product lot.As manufacturer investigation of this complaint by leica biosystems is in progress, the root cause of this event has not yet been determined.
Event or Problem Description
On 25 september 2025, leica biosystems received a complaint detailing "the plastic seems quite flimsy, and staff have had issues with them closing properly." on 18 october 2025, the leica account manager advised the leica associate, quality assurance that the awareness date for this event was 21 august 2025.
Additional Manufacturer Narrative
Retain samples were not available for further testing.The root cause for "the plastic seems quite flimsy, and staff have had issues with them closing properly" reported by the customer could not be unequivocally determined from the information available.Although the information available indicates that no adverse consequence(s) to a patient(s) has been reported to the manufacturer, the circumstances involved in this complaint have previously resulted in serious injury.If additional information is received an additional follow up mdr will be submitted.

• Brand Name: ACTIVFLO ROUTINE I-TAPED- BLUE 1000
• Common Device Name: CASSETTES, TISSUE
• Manufacturer (Section D): XIAMEN VOKE MOLD & PLASTIC ENGINEER; no. 1152-1160 and no.1166-1170; chun guang rd,; xiamen city, fujian province 00003 6110; CH 0000361101
• Manufacturer (Section G): XIAMEN VOKE MOLD & PLASTIC ENGINEER; no. 1152-1160 and no.1166-1170; 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: 23362929
• Report Number: 1419341-2025-00036
• Device Sequence Number: 8965164
• Product Code: IDZ
• UDI-Device Identifier: 20849832022378
• UDI-Public: 20849832022378
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 11/05/2025

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- BLUE 1000
• Device Catalogue Number: 39LC-500-2-L
• Device Lot Number: 20250307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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