MAUDE Adverse Event Report: ERIE SCIENTIFIC COMPANY BOND PLUS SLIDES; SLIDES, MICROSCOPE

Model Number	BOND PLUS SLIDES
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported tissue section were falling off of bond plus slides, p/n s21.2113.A, lot 060325-9.No adverse events were reported.Trending analysis from 30 sep 2024 to 20 sep 2025 reported no (0) other related occurrences of this issue for this product lot.The product history was reviewed and no issues were identified in the manufacturing record for this product that would cause or contribute to the problem reported in this complaint and there have been no prior complaints for this same batch/lot number.The root cause for the "section dropping off from the slide" 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 a follow up mdr will be submitted.
Event or Problem Description
On 24 september 2025, leica biosystems received a complaint detailing "section dropping off from the slide".On 30 september 2025, the leica biosystems customer service executive provided the following additional information "¿the issue is sections falling off their bond plus slide".As of 22 october 2025, leica biosystems has not received information as to either the final status of the patient tissue samples involved in this event or the patient impact/outcome.No adverse consequence(s) to a patient(s) has been reported to the manufacturer.Although the information available indicates that there has been no adverse impact reported to the manufacturer in association with the circumstances involved in this complaint, the circumstances involved in this complaint have previously resulted in serious injury and are considered a malfunction.

• Brand Name: BOND PLUS SLIDES
• Common Device Name: SLIDES, MICROSCOPE
• Manufacturer (Section D): ERIE SCIENTIFIC COMPANY; 20 post road; portsmouth NH 03801
• Manufacturer (Section G): ERIE SCIENTIFIC COMPANY; 20 post road; portsmouth NH 03801
• Manufacturer Contact: heather jensen ; 5205 us-12; richmond, IL 60071 ; 8152988371
• MDR Report Key: 23362817
• Report Number: 1419341-2025-00035
• Device Sequence Number: 21073915
• Product Code: KEW
• UDI-Device Identifier: 20849832023108
• UDI-Public: 20849832023108
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 10/22/2025

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: BOND PLUS SLIDES
• Device Catalogue Number: S21.2113.A
• Device Lot Number: 060325-9
• 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: 09/24/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2025
• 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