BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PN 31G 6MM 3B

    MDR report key: 10570981 · Received September 22, 2020

    Report

    Report Number
    9616656-2020-00945
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    August 25, 2020
    Report Date
    September 30, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES OR PHOTOS WERE RETURNED FOR ANALYSIS. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THE BD PN 31G 6MM 3B WAS DIFFICULT TO OPERATE OR NOT WORKING/FUNCTIONING. THIS EVENT OCCURRED 6 TIMES WITH 3 DIFFERENT LOT NUMBERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE PATIENT IS UNABLE TO SCREW THE NEEDLES CORRECTLY ONTO THE PEN."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9288374, MEDICAL DEVICE EXPIRATION DATE: 2024-10-31, DEVICE MANUFACTURE DATE: 2019-10-15, MEDICAL DEVICE LOT #: 9275394, MEDICAL DEVICE EXPIRATION DATE: 2024-09-30, DEVICE MANUFACTURE DATE: 2019-10-02, MEDICAL DEVICE LOT #: 9121509, MEDICAL DEVICE EXPIRATION DATE: 2024-05-31, DEVICE MANUFACTURE DATE: 2019-05-01. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THE BD PN 31 G 6 MM 3B WAS DIFFICULT TO OPERATE OR NOT WORKING/FUNCTIONING. THIS EVENT OCCURRED 6 TIMES WITH 3 DIFFERENT LOT NUMBERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE PATIENT IS UNABLE TO SCREW THE NEEDLES CORRECTLY ONTO THE PEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035499 BD PN 31G 6MM 3B HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other