BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 11506987 · Received March 17, 2021

    Report

    Report Number
    1213809-2021-00137
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 18, 2021
    Report Date
    March 11, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1008801, MEDICAL DEVICE EXPIRATION DATE: 2025-12-31, DEVICE MANUFACTURE DATE: 2021-01-08. MEDICAL DEVICE LOT #: 1006217, MEDICAL DEVICE EXPIRATION DATE: 2025-12-31, DEVICE MANUFACTURE DATE: 2021-01-06 . INVESTIGATION SUMMARY: ONE PHOTO AND 477 3ML SYRINGES (P/N 309657) IN FULLY SEALED BLISTER PACKS WERE RECEIVED AND EVALUATED. TWO WERE FROM BATCH 0253516. NINETEEN WERE FROM BATCH 0336096. 180 WERE FROM BATCH 1008801. 276 WERE FROM BATCH 1006217. ALL THE SYRINGES WERE VISUALLY INSPECTED WITH SOME APPEARING TO HAVE AN ANGLED STOPPER CONDITION. THE SYRINGES WITH THE LARGEST DEGREE OF STOPPER ANGULARITY WERE MEASURED PER PROCEDURE. ALL THE STOPPERS WERE CONFIRMED TO BE ACCEPTABLE PER PRODUCT SPECIFICATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE FOR THE ANGLED STOPPER DEFECT MAY BE ASSOCIATED WITH THE ASSEMBLY PROCESS. SINCE THE DEFECTS OBSERVED ARE WITHIN THE ACCEPTABLE LIMITS, NO CORRECTIVE ACTIONS ARE NECESSARY. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: THE SYRINGES WITH THE LARGEST DEGREE OF STOPPER ANGULARITY WERE MEASURED PER PROCEDURE. ALL THE STOPPERS WERE CONFIRMED TO BE ACCEPTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE ANGLED STOPPER DEFECT MAY BE ASSOCIATED WITH THE ASSEMBLY PROCESS. SINCE THE DEFECTS OBSERVED ARE WITHIN THE ACCEPTABLE LIMITS, NO CORRECTIVE ACTIONS ARE NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD 60ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED MISALIGNED STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK STOPPER (SEAL) IS NOT STRAIGHT ACROSS. IT IS CROOKED AND DOES NOT LINE UP WITH VOLUME INDICATORS. NO PATIENT CARE ISSUES THAT WE KNOW OF. NO LEAKAGE THAT WE KNOW OF. PEI HAS FOUND INTEGRITY ISSUES WITH SOME PLUNGERS IN THE BD 3ML SYRINGES. PEI HAD INCREASED USE OF THE 3ML SYRINGES WHEREVER POSSIBLE TO SAVE INVENTORY OF 1ML SYRINGES. WE ARE GOING BACK TO THE 1ML SYRINGES. I AM NOT SURE IF THE 3ML ARE USED FOR COVID VACCINE. BD LOT NUMBERS FOUND WITH THE INTEGRITY ISSUES ARE: 1008801, 1006217.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407056 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1006217

    Patients

    Seq Age Sex Outcome Treatment
    1