BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 23G 1-1/4IN

    MDR report key: 9991779 · Received April 23, 2020

    Report

    Report Number
    8041187-2020-00223
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    April 3, 2020
    Report Date
    April 30, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/14/2020. H.6. INVESTIGATION: FIVE ACTUAL SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. ONE OF THE SAMPLES WAS FROM NIPRO AND MISTAKENLY SENT SO ONLY FOUR OF THE SAMPLES WERE EVALUATED. THOSE FOUR SAMPLES WERE SUBJECTED TO VISUAL INSPECTION AND PERFORATION TESTING. THE SAMPLES FAILED THE PERFORATION TEST AS THEY WERE UNABLE TO BE SEPARATED; THEREFORE, THE INCIDENT COULD BE VERIFIED. AT THE PACKAGING PERFORATION STATION, THERE IS A PERFORATION KNIFE TO CREATE PERFORATED CUTS. BASED ON THE INVESTIGATION, THE PROBABLE ROOT CAUSE COULD BE DUE TO THE PERFORATION KNIFE WEAR AND TEAR, CAUSING THE UNCLEAR PERFORATION CUT LINES AND THE PRODUCTION TECHNICIAN MAY HAVE BEEN UNABLE TO DETECT THE GOOD AND BAD PERFORATION CUT LINES, HENCE PARTS FLOW TO NEXT PROCESS. DHR FOR PACKAGED NEEDLE (PN) WAS PERFORMED FOR BATCH 9112914 (CATALOG 302008) NO QUALITY NOTIFICATION WAS RAISED FOR PAST 12 MONTHS ON POOR PERFORATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS POOR PERFORATION OF PACKAGING THUS COMPROMISING STERILITY WITH A BD NEEDLE 23G 1-1/4IN. THIS OCCURRED ON 100 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ATTEMPTING TO SEPARATE THE INDIVIDUAL NEEDLES, THE PERFORATIONS IN THE PLASTIC AND PAPER ARE NOT AT TIMES COMPLETE, SO THE COVERS TEAR. THIS REQUIRES THE UNIT TO BE DISPOSED AS THE STERILITY IS COMPROMISED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POOR PERFORATION OF PACKAGING THUS COMPROMISING STERILITY WITH A BD NEEDLE 23G 1-1/4IN. THIS OCCURRED ON 100 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ATTEMPTING TO SEPARATE THE INDIVIDUAL NEEDLES, THE PERFORATIONS IN THE PLASTIC AND PAPER ARE NOT AT TIMES COMPLETE, SO THE COVERS TEAR. THIS REQUIRES THE UNIT TO BE DISPOSED AS THE STERILITY IS COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455406 BD NEEDLE 23G 1-1/4IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 9112914

    Patients

    Seq Age Sex Outcome Treatment
    1 Other