BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25GA 1IN

    MDR report key: 11103515 · Received December 31, 2020

    Report

    Report Number
    3002682307-2020-00439
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    December 4, 2020
    Report Date
    January 18, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 200420 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. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN UNCOMMON ISSUE WITH A LOW CHANCE OF RECURRENCE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE 25GA 1IN HAD THE INCORRECT LENGTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER STATES THAT ADVISED THAT AROUND 95% OF THE STOCK IS FAULTY, AS NEEDLES INSIDE THE BOXES HAVE VARYING LENGTHS."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE 25GA 1IN HAD THE INCORRECT LENGTH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER STATES THAT ADVISED THAT AROUND 95% OF THE STOCK IS FAULTY, AS NEEDLES INSIDE THE BOXES HAVE VARYING LENGTHS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567882 NEEDLE 25GA 1IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 200420

    Patients

    Seq Age Sex Outcome Treatment
    1