BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M

    MDR report key: 11337135 · Received February 17, 2021

    Report

    Report Number
    11337135
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    February 11, 2021
    Report Date
    February 15, 2021
    Manufacturer
    3M COMPANY
    Product Code
    FXX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFECTION CONTROL AT (B)(6) MEDICAL CENTER WAS REVIEWING A NEW SHIPMENT OF 3M COMPANY N95 SURGICAL MASKS THAT HAD BEEN RECENTLY DELIVERED PRIOR TO MASS DISTRIBUTION. THE DIRECTOR OF INFECTION CONTROL ASKED AN INFECTION PREVENTIONIST TO RESEARCH THE LOT NUMBER TO ENSURE THAT THESE WERE LEGITIMATE 3M SURGICAL MASKS IN LIGHT OF THE RECENT REPORTS OF COUNTERFEIT MASKS BEING CIRCULATED IN THE US. THE INFECTION PREVENTIONIST CONTACTED THE 3M FRAUD HOT LINE ON [DATE REDACTED] TO REVIEW THE PRODUCT. PICTURES OF THE MASK AND BOX WERE SENT TO THE 3M [email protected]. THE NEXT MORNING OF 3M FRAUD HOT LINE INFORMED US THAT THE N95 SURGICAL MASKS 1860 AND 1860 SMALL WITH LOT NUMBERS B20018 AND B20522 WERE IN FACT COUNTERFEIT MASKS. AN ADDITIONAL LOT NUMBER WAS SUBMITTED ON [DATE REDACTED] (1860/LOT NUMBER B20183). 3M DID CONFIRM ON [DATE REDACTED] THAT THE 3RD LOT NUMBER WAS ALSO COUNTERFEITED. THE 3M COVID FRAUD HOTLINE ADVISE NOT TO USE THE COUNTERFEITED PRODUCT FROM THE SELLER. LEADERSHIP AND MATERIALS MANAGEMENT WERE IMMEDIATELY NOTIFIED [DATE REDACTED]. AN EMERGENCY MEETING WAS CONDUCTED OF ALL KEY STAKEHOLDERS. ALL MASKS WERE PULLED BACK FROM BOTH INPATIENT AND AMBULATORY LOCATIONS AND EXCHANGED BY 3M FLAT FOLD MASKS, NOT INCLUDED IN THE LOT NUMBERS IDENTIFIED AS COUNTERFEITED.

    Description of Event or Problem · 1

    INFECTION CONTROL WAS REVIEWING A NEW SHIPMENT OF 3M COMPANY N95 SURGICAL MASKS THAT HAD BEEN RECENTLY DELIVERED PRIOR TO MASS DISTRIBUTION. THE DIRECTOR OF INFECTION CONTROL ASKED AN INFECTION PREVENTIONIST TO RESEARCH THE LOT NUMBER TO ENSURE THAT THESE WERE LEGITIMATE 3M SURGICAL MASKS IN LIGHT OF THE RECENT REPORTS OF COUNTERFEIT MASKS BEING CIRCULATED IN THE US. THE INFECTION PREVENTIONIST CONTACTED THE 3M FRAUD HOT LINE ON [DATE REDACTED] TO REVIEW THE PRODUCT. PICTURES OF THE MASK AND BOX WERE SENT TO THE 3M [email protected]. THE NEXT MORNING OF 3M FRAUD HOT LINE INFORMED US THAT THE N95 SURGICAL MASKS 1860 AND 1860 SMALL WITH LOT NUMBERS B20018 AND B20522 WERE IN FACT COUNTERFEIT MASKS. AN ADDITIONAL LOT NUMBER WAS SUBMITTED ON [DATE REDACTED] (1860/LOT NUMBER B20183). 3M DID CONFIRM ON [DATE REDACTED] THAT THE 3RD LOT NUMBER WAS ALSO COUNTERFEITED. THE 3M COVID FRAUD HOTLINE ADVISE NOT TO USE THE COUNTERFEITED PRODUCT FROM THE SELLER. LEADERSHIP AND MATERIALS MANAGEMENT WERE IMMEDIATELY NOTIFIED [DATE REDACTED]. AN EMERGENCY MEETING WAS CONDUCTED OF ALL KEY STAKEHOLDERS. ALL MASKS WERE PULLED BACK FROM BOTH INPATIENT AND AMBULATORY LOCATIONS AND EXCHANGED BY 3M FLAT FOLD MASKS, NOT INCLUDED IN THE LOT NUMBERS IDENTIFIED AS COUNTERFEITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233079 3M MASK, SURGICAL FXX 3M COMPANY B20522

    Patients

    Seq Age Sex Outcome Treatment
    1