BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25GA 1IN

    MDR report key: 11098228 · Received December 30, 2020

    Report

    Report Number
    3002682307-2020-00437
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    December 2, 2020
    Report Date
    January 19, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 200420. D.4. MEDICAL DEVICE EXPIRATION DATE: 3/31/2025. H.4. DEVICE MANUFACTURE DATE: 4/21/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 200420, WHICH WAS OBTAINED FROM THE PRODUCT INFORMATION CAPTURED WITHIN THE PROVIDED PICTURE SAMPLES, AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE PICTURES SHOWED FIVE BLISTER PACKAGES CONTAINING NEEDLES. TWO OF THE NEEDLES WERE OBSERVED SHORTER THAN THE REST OF THE SAMPLES PICTURED. WITHOUT THE PHYSICAL SAMPLES, IT IS NOT POSSIBLE TO CONFIRM WHETHER THE ISSUE IS RELATED TO A MIX-UP OF THE CANNULA LENGTH OR A DEFECT IN THE CANNULA MANUFACTURING. THE MANUFACTURING RECORDS WERE ANALYZED TO IDENTIFY A POSSIBLE CAUSE FOR THIS INCIDENT. THE LOT NUMBER IN QUESTION, 200420, WAS PACKAGED APRIL 27, 2020 THROUGH APRIL 30, 2020. PRIOR TO THE PACKAGING OF THIS LOT, TWO DIFFERENT NEEDLE TYPES WERE PACKAGED ON THE LINE. THE TWO PREVIOUSLY PACKAGED NEEDLES HAD CREAM COLORED HUBS AND BLUE COLORED HUBS; THEREFORE, IT IS NOT POSSIBLE THAT THIS INCIDENT RESULTED FROM AN ISSUE RELATED TO LINE CLEARANCE BETWEEN THE PRODUCTION OF EACH PRODUCT. PRIOR TO THE ASSEMBLY OF THIS LOT, TWO DIFFERENT NEEDLE TYPES WERE ASSEMBLED ON THE LINE. THE TWO PREVIOUSLY ASSEMBLED NEEDLES HAD GRAY COLORED HUBS AND BROWN COLORED HUBS; THEREFORE, IT IS AGAIN NOT POSSIBLE THAT THIS INCIDENT RESULTED FROM AN ISSUE RELATED TO LINE CLEARANCE BETWEEN THE ASSEMBLY OF EACH PRODUCT. THE ADJACENT ASSEMBLY MACHINE WAS NOT MANUFACTURING MICROLANCE NEEDLES, THEREFORE, THERE WAS NO POTENTIAL RISK OF PRODUCT MIX UP BETWEEN THE TWO LINES. PLASTIC BOXES ARE USED TO TRANSPORT THE NEEDLES FROM THE ASSEMBLY MACHINE TO THE FEEDER OF THE PACKAGING MACHINE. IN ADDITION, THE ASSEMBLY NEEDLES ARE PROTECTED BY SINGLE USE PLASTIC BAGS INSIDE OF THE BOXES. IT IS POSSIBLE THAT A HUMAN ERROR DURING THE TRANSPORT OF THE NEEDLES IN THE MANUFACTURING FACILITY WENT UNDETECTED AND RESULTED IN THIS INCIDENT; HOWEVER, THIS CANNOT BE CONFIRMED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 0.5 INCH NEEDLES WERE FOUND MIXED INTO THE SAME PACKAGING STRIP AS THE NEEDLES 25GA 1IN. THIS OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE AN ISSUE WITH THE NEEDLES WE PURCHASED; 1 INCH AND 0.5 INCH NEEDLES SEEM TO HAVE BEEN MIXED IN THE SAME PACKAGING STRIP."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 0.5 INCH NEEDLES WERE FOUND MIXED INTO THE SAME PACKAGING STRIP AS THE NEEDLES 25GA 1IN. THIS OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE AN ISSUE WITH THE NEEDLES WE PURCHASED; 1 INCH AND 0.5 INCH NEEDLES SEEM TO HAVE BEEN MIXED IN THE SAME PACKAGING STRIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558410 NEEDLE 25GA 1IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 200420

    Patients

    Seq Age Sex Outcome Treatment
    1