BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER CONTACT-ACTIVATED LANCET

    MDR report key: 9945636 · Received April 9, 2020

    Report

    Report Number
    2243072-2020-00579
    Event Type
    Malfunction
    Date Received
    April 9, 2020
    Date of Event
    January 21, 2020
    Report Date
    April 15, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DESCRIPTION, MEDICAL DEVICE BRAND NAME, COMMON DEVICE NAME, MEDICAL DEVICE TYPE, DEVICE EXPIRATION DATE, DEVICE MANUFACTURE DATE, UNIQUE IDENTIFIER NUMBER, PMA/510(K)#, AND DEVICE MANUFACTURE DATE HAVE BEEN UPDATED. THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD MICROTAINER® CONTACT-ACTIVATED LANCET EXPERIENCED A BREACH IN STERILITY WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN TRYING TO OPEN A LANCET TO TAKE DEXTROSTIX, HE REALIZES THAT THE PIVOT IS VERY HARD, IS COMPLETELY STUCK AND BREAKS DUE TO DIFFICULT HANDLING. D.1. MEDICAL DEVICE BRAND NAME: BD MICROTAINER® CONTACT-ACTIVATED LANCET. D.1. COMMON DEVICE NAME: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE. D.2. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON DE MEXICO. D.2. MEDICAL DEVICE TYPE: FMK. D.4. MEDICAL DEVICE CATALOG #: 366592. D.4. MEDICAL DEVICE LOT #: Z9E29H6. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: BECTON DICKINSON DE MEXICO. G.5. PMA/510(K)#: EXEMPT. H.4. DEVICE MANUFACTURE DATE: 2019-08-22.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROTAINER® CONTACT-ACTIVATED LANCET EXPERIENCED A BREACH IN STERILITY WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN TRYING TO OPEN A LANCET TO TAKE DEXTROSTIX, HE REALIZES THAT THE PIVOT IS VERY HARD, IS COMPLETELY STUCK AND BREAKS DUE TO DIFFICULT HANDLING.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INVESTIGATION SUMMARY: THE CUSTOMER DID NOT PROVIDE BD PAS WITH PRODUCT CATALOG NUMBER OR LOT NUMBER INFORMATION, WHEN REQUESTED. AFTER 3-FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, BD PAS HAS CLOSED THIS CUSTOMER COMPLAINT. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD MICROTAINER CONTACT ACTIVATED LANCET EXPERIENCED A BREACH IN STERILITY WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN TRYING TO OPEN A LANCET TO TAKE DEXTROSTIX, HE REALIZES THAT THE PIVOT IS VERY HARD, IS COMPLETELY STUCK AND BREAKS DUE TO DIFFICULT HANDLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409101 BD MICROTAINER CONTACT-ACTIVATED LANCET MANUAL SURGICAL INSTRUMENT FOR GENERAL USE FMK BECTON DICKINSON DE MEXICO Z9E29H6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other