MAUDE Adverse Event Report: ECOLAB/MICROTEK INC MICROTEK; ADHESION GENERAL PURPOSE PROBE COVER

Model Number	APC1292
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the covers were stuck together and broke when used.No patient injury, infections or complications were reported.

• Brand Name: MICROTEK
• Common Device Name: ADHESION GENERAL PURPOSE PROBE COVER
• Manufacturer (Section D): ECOLAB/MICROTEK INC; 1 ecolab place; st. paul MN 55102
• Manufacturer (Section G): MICROTEK DOMINICANA S.A; zona franca no.2; la romana, la romana ; DR
• Manufacturer Contact: yarina montas ; 1 ecolab place; st. paul, MN
• MDR Report Key: 18916385
• Report Number: 8043817-2024-00005
• Device Sequence Number: 6759973
• Product Code: PUI
• UDI-Device Identifier: 00748426107407
• UDI-Public: 00748426107407
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2024

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
• Device Expiration Date: 12/19/2025
• Device Model Number: APC1292
• Device Lot Number: 1482LRE200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• 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