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

Model Number	GPC396EU
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a procedure, blood was observed on the tip of the probe after removing the sterile disposable cover.The cover was probably damaged during the procedure or was defective.No patient complications were have been reported as a result of this event.

• Brand Name: GENERAL PURPOSE PROBE COVER
• Common Device Name: GENERAL PROBE COVER
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL; 1 ecolab place; st paul MN 55102
• MDR Report Key: 9365898
• Report Number: 8043817-2019-40035
• Device Sequence Number: 11506429
• Product Code: KKX
• UDI-Device Identifier: 50748426090209
• UDI-Public: 50748426090209
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K882724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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 Expiration Date: 05/26/2024
• Device Model Number: GPC396EU
• Device Lot Number: D191261
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1