BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE 3 NEEDLES

    MDR report key: 10906511 · Received November 25, 2020

    Report

    Report Number
    3002682307-2020-00372
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 30, 2020
    Report Date
    November 30, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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 190728 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE UNAVAILABLE FOR RETURN, OUR QUALITY TEAM OBTAINED TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THE RETAINED NEEDLES WERE ASSEMBLED WITH AN EMERALD SYRINGE BY POSITIONING THE HUB IN THE SYRINGE TIP WITH A SLIGHTLY ROTATIONAL MOVEMENT. NONE OF THE RETAINED SAMPLES TESTED SHOWED SIGNS OF DEFECT AND NO CLOGGING CONDITIONS WERE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT. DURING THE CANNULA ASSEMBLY PROCESS, ALL PRODUCT IS INSPECTED FOR SIGNS OF DEFECT. A CAMERA SYSTEM SENSES A LIGHT SOURCE WHICH IS POSITIONED AT THE OPPOSITE END OF THE NEEDLE. IF THE CAMERA DOES NOT SENSE THE LIGHT SOURCE, AN OCCLUSION CONDITION MAY BE PRESENT AND THE NEEDLE IS AUTOMATICALLY REJECTED. IN ADDITION TO THE CAMERA SYSTEM, PRODUCT CONDITION IS REVIEWED AS A PART OF THE IN-PROCESS INSPECTION PROCESS AFTER ASSEMBLY AND PRIOR TO THE RELEASE OF EACH BATCH PRODUCED. THE MEDICATION USED COULD POTENTIALLY RESULT IN CLOGGING CONDITIONS. IN CERTAIN CIRCUMSTANCES, THE DRUG USED CAN BECOME DEPOSITED WITHIN THE CANNULA, CAUSING THE NEEDLE TO BECOME BLOCKED DUE TO CRYSTALLIZATION EFFECTS. OCCLUSION IS MOST LIKELY TO OCCUR IF A DRUG REMAINS WITHIN THE NEEDLE FOR AN EXTENDED PERIOD OF TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE EXPERIENCED A CLOGGED/BLOCKED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DECAPEPTYL DEPOT 3,75MG-IL: THE NEEDLE IS BLOCKED, THE SUSPENSION WON'T GO THROUGH. REASON: NEEDLE IS BLOCKED. CLASSIFICATION : MINOR (CAN BE RE-EVALUATE). PRODUCT CONCERNED: ITEM : 2011050028, DESCRIPTION : NEEDLE 21GX1.5 - 0.8X40MM GREEN, BATCH NUMBER : 190728. THE PATIENT IS A PHARMACIST WHO'S DOING THE MONTHLY INJECTIONS BY HERSELF. THE PATIENT REPORTS THAT WHEN SHE CHANGED THE THICK RECONSTITUTION NEEDLE TO THE THINNER INJECTION NEEDLE AND WANTED TO INJECT, IT FELT AS IF THE NEEDLE IS BLOCKED. SHE SAID IT'S NOT A PROBLEM IN THE SUSPENSION VISCOSITY BECAUSE EVEN WHEN SHE CALLED OUR OFFICE THE SUSPENSION WAS STILL LIQUID AND FLOWING. SHE SAID THIS HAD HAPPENED TO HER BEFORE AND SHE CHANGED THE NEEDLE TO A NEEDLE WITH THE SAME WIDTH THAT SHE PURCHASED SEPARATELY, BUT THIS TIME SHE DIDN'T HAVE THE EXTRA NEEDLE. SHE ALSO MENTIONED THAT WHEN USING THE RECONSTITUTION THICKER NEEDLE, THE SUSPENSION GOES THROUGH, BUT THE NEEDLE IS TO WIDE TO PENETRATE THE SKIN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. 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 BD MICROLANCE¿ 3 NEEDLE EXPERIENCED A CLOGGED/BLOCKED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DECAPEPTYL DEPOT 3,75MG-IL: THE NEEDLE IS BLOCKED, THE SUSPENSION WON'T GO THROUGH. REASON: NEEDLE IS BLOCKED. CLASSIFICATION : MINOR (CAN BE RE-EVALUATE). PRODUCT CONCERNED: ITEM : 2011050028, DESCRIPTION : NEEDLE 21GX1.5 - 0.8X40MM GREEN, BATCH NUMBER : 190728. THE PATIENT IS A PHARMACIST WHO'S DOING THE MONTHLY INJECTIONS BY HERSELF. THE PATIENT REPORTS THAT WHEN SHE CHANGED THE THICK RECONSTITUTION NEEDLE TO THE THINNER INJECTION NEEDLE AND WANTED TO INJECT, IT FELT AS IF THE NEEDLE IS BLOCKED. SHE SAID IT'S NOT A PROBLEM IN THE SUSPENSION VISCOSITY BECAUSE EVEN WHEN SHE CALLED OUR OFFICE THE SUSPENSION WAS STILL LIQUID AND FLOWING. SHE SAID THIS HAD HAPPENED TO HER BEFORE AND SHE CHANGED THE NEEDLE TO A NEEDLE WITH THE SAME WIDTH THAT SHE PURCHASED SEPARATELY, BUT THIS TIME SHE DIDN'T HAVE THE EXTRA NEEDLE. SHE ALSO MENTIONED THAT WHEN USING THE RECONSTITUTION THICKER NEEDLE, THE SUSPENSION GOES THROUGH, BUT THE NEEDLE IS TO WIDE TO PENETRATE THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372097 BD MICROLANCE 3 NEEDLES LANCET FMK BECTON DICKINSON, S.A. 190728

    Patients

    Seq Age Sex Outcome Treatment
    1