BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSEMBLY FIXTURE M12

    MDR report key: 11572604 · Received March 25, 2021

    Report

    Report Number
    2243072-2021-00879
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    February 26, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON, S.A. (SAN AGUSTIN). G.1. MANUFACTURING LOCATION: BECTON DICKINSON, S.A. (SAN AGUSTIN). D.4. MEDICAL DEVICE LOT#: 1910003. H.6. INVESTIGATION: THREE FIXTURES AND ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE PHOTO, THE LABEL DISPLAYS ITEM 515400 M12 ASSEMBLY FIXTURE AND THE PRODUCT WITHIN WAS CONFIRMED TO BE ITEM 515400. TWO ADDITIONAL FIXTURES WERE RECEIVED IN AN ALTERNATE PACKAGE, HOWEVER, BOTH FIXTURES WERE VERIFIED TO BE ITEM 515400. A REVIEW OF DEVICE RECORDS WAS PERFORMED FOR LOTS 1910003 AND 1910002, ALL PRODUCT WAS VERIFIED TO BE MANUFACTURED ACCORDING TO SPECIFICATION. PRODUCT UNDERGOES 100% INSPECTION BEFORE RELEASE, INCLUDING VERIFICATION OF THE PROPER PRODUCT LABELING, NO ISSUES WERE IDENTIFIED RELATED TO THE REPORTED ISSUE. BASED ON OUR QUALITY TEAM'S INVESTIGATION AND THE SAMPLE EVALUATION, NO PRODUCT DEFECT WAS IDENTIFIED AS THE CASE LABELING AND PRODUCT WITHIN WAS VERIFIED TO BE ITEM 515400. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ASSEMBLY FIXTURE M12 HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER ORDERED PHASEAL ASSEMBLY FIXTURE REF (B)(4) BUT RECEIVED (B)(4). THE BOX IS WRONGLY LABELD WITH (B)(4).

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A 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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. PMA/510(K)#: NOT A MEDICAL DEVICE. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ASSEMBLY FIXTURE M12 HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER ORDERED PHASEAL ASSEMBLY FIXTURE REF 515400 BUT RECEIVED 518082. THE BOX IS WRONGLY LABELED WITH 515400.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467900 ASSEMBLY FIXTURE M12 PHASEAL ONB BECTON DICKINSON, S.A. 1910003

    Patients

    Seq Age Sex Outcome Treatment
    1