BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 23G 1IN TW

    MDR report key: 9960040 · Received April 14, 2020

    Report

    Report Number
    8041187-2020-00208
    Event Type
    Malfunction
    Date Received
    April 14, 2020
    Date of Event
    March 25, 2020
    Report Date
    October 26, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    MDS-20-3808
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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: 3/30/2020 H.6. INVESTIGATION: FIVE ACTUAL SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THREE NEEDLE PRODUCTS WERE OBSERVED TO BE OUT OF THE PACKAGING. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THERE WAS NO SEALING TRANSFER ON THE BOTTOM WEB FOR FOUR SAMPLES, INDICATING AN OPEN SEAL. IT WAS ALSO OBSERVED THAT THE FOUR OPEN SEAL SAMPLES HAD POOR PERFORATION. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO POOR PERFORATION WERE FOUND. HOWEVER, A DAMAGED GASKET THE COULD LEAD TO OPEN SEAL WAS DETECTED AND THE DAMAGED GASKET WAS CHANGED. A DAMAGED GASKET COULD BE THE CAUSE FOR THE ASSEMBLED NEEDLE TO BE OUT OF THE BLISTER POCKET. DURING SEALING, THE SEALING DIE WAS NOT ABLE TO FULLY CLOSE RESULTING IN POOR/ OPEN SEALING. THE IMPROPER SEALING CAUSED THE PERFORATION KNIFE TO BE UNABLE TO CREATE CLEAR PERFORATION INTERVAL CUTS ON THE UNIT PACKAGE RESULTING IN POOR PERFORATION. FURTHER INVESTIGATION, CAPA#1568043, IS BEING DONE TO UNDERSTAND ALL POTENTIAL FAILURE MODES.

    Additional Manufacturer Narrative · 0

    BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL (MDS-20-3808) FOR A SINGLE LOT OF THE BD 23G NEEDLE. PACKAGING DEFECTS WERE OBSERVED ON A NUMBER OF SAMPLES FROM THE LOT WHICH MAY LEAD TO POOR PERFORATION LEADING TO STERILE FIELD CONTAMINATION, OR OPEN SEALS. THE ROOT CAUSE INVESTIGATION IS ONGOING AND WILL BE DOCUMENTED IN CAPA # 1568043.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 NEEDLES 23G 1IN TW EXPERIENCED POOR PERFORATION ON PACKAGING WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLISTER PACKAGE WRONG CUTTING. WHEN CUSTOMER OPENED THE NEEDLE PACKAGE, SEVERAL NEEDLE OPENED BECAUSE OF WRONG PACKAGE CUTTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 NEEDLES 23G 1IN TW EXPERIENCED POOR PERFORATION ON PACKAGING WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLISTER PACKAGE WRONG CUTTING. WHEN CUSTOMER OPENED THE NEEDLE PACKAGE, SEVERAL NEEDLE OPENED BECAUSE OF WRONG PACKAGE CUTTING.

    Additional Manufacturer Narrative · 1

    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 5 NEEDLES 23G 1IN TW EXPERIENCED POOR PERFORATION ON PACKAGING WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLISTER PACKAGE WRONG CUTTING. WHEN CUSTOMER OPENED THE NEEDLE PACKAGE, SEVERAL NEEDLE OPENED BECAUSE OF WRONG PACKAGE CUTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420006 NEEDLE 23G 1IN TW NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 9358108

    Patients

    Seq Age Sex Outcome Treatment
    1