BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL

    MDR report key: 19604850 · Received June 25, 2024

    Report

    Report Number
    3003152976-2024-00369
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    June 18, 2024
    Report Date
    October 30, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903012299
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: TWO PHOTOS AND THREE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE PHOTOS, THE ENTIRE TIP AND LUER THREADING IS OBSERVED TO BE BROKEN OFF. THE RETURNED SAMPLES WERE EVALUATED, NO DAMAGE WAS OBSERVED WITHIN ANY OF THE DEVICES, ALL TIPS AND LUER THREADING IS PROPERLY FORMED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 2306005, 2310002 AND 2010001, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES OF EACH LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS VISUALLY INSPECTED, THE TIPS WERE VERIFIED TO BE PROPERLY MOLDED AND NO DAMAGE OR OTHER DEFECTS WITHIN THE TIP OR LUER THREADING WERE OBSERVED. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. NO ISSUES RELATED TO THE REPORTED EVENT WERE FOUND. BASED ON THE AVAILABLE INFORMATION AND GIVEN THE DEVICE RECORDS DID NOT IDENTIFY ANY FAILURES RELATED TO THIS INCIDENT; WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED VIA EMAIL: I¿M EMAILING TODAY AS WE¿VE HAD AN ISSUE WITH ONE OF OUR SYRINGES. WE¿RE UNSURE OF THE EXACT BATCH NUMBER OF THE IMPACTED SYRINGE BUT THE DETAILS OF THE ONES WE HAVE IN STOCK ARE BELOW: PRODUCT NAME: SYRINGE 30ML LL, CATALOG NUMBER: 301229, BATCH NUMBER: 2310002, EXPIRATION DATE: 2028/09/30, BATCH NUMBER: 2306005, EXPIRATION DATE: 2028/05/31, BATCH NUMBER: 201001, EXPIRATION DATE: 2025-09-30, I¿VE ATTACHED IMAGES (PATIENT DETAILS HIDDEN) OF THE DAMAGE THAT HAS OCCURRED TO THE SYRINGE. AS CAN BE SEEN, THE LUER LOK MECHANISM HAS COMPLETELY SHEARED OFF. OUR ORGANIZATION IS CURRENTLY UNDERTAKING AN INVESTIGATION TO DETERMINE HOW THIS MAY HAVE HAPPENED. THE SYRINGE WAS SEALED IN A LOCKBOX WHILST ADMINISTERING THE DRUGS SO IT IS HIGHLY UNLIKELY THAT THEY HAVE BEEN TAMPERED WITH DURING DRUG ADMINISTRATION. IS BD AWARE OF ANY ISSUES RELATING TO THESE BATCHES? ADDITIONAL INFORMATION: I HAVE SPOKEN WITH THE WARD MANAGER AND RECEIVED THE FOLLOWING RESPONSE REGARDING ANY IMPACT ON THE PATIENT: ¿THE PATIENT MISSED OUT ON POSSIBLY UP TO 2 HOURS OF MEDICINE ADMINISTRATION, HOWEVER DID NOT REQUIRE ANY ADDITIONAL MEDICATION AT THE TIME.¿

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208875 SYRINGE 30ML LL SYRINGE, PISTON FMF BECTON DICKINSON UNKNOWN 00382903012299

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown