BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 19739810 · Received July 15, 2024

    Report

    Report Number
    1911916-2024-00502
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 28, 2024
    Report Date
    July 25, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 FOR DEVICE EVALUATION. IT WAS REPORTED THERE ARE SYRINGES WITHOUT CORRECT LABELING DOSAGE NUMBERS AND LINES. TO AID IN THE INVESTIGATION, TWENTY-ONE SAMPLES IN SEALED PACKAGING BLISTERS AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. NINETEEN SAMPLES HAVE NO SYRINGE BARREL SCALE MARKING, THE OTHER TWO SAMPLES HAVE AN INCOMPLETE SYRINGE BARREL SCALE MARKING, THE TWO PHOTOS PROVIDED SHOW THE SYRINGES WITH A MISSING SYRINGE BARREL SCALE MARKING. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE SYRINGE BARREL PRINTING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 4080219. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL #:309653 BATCH#:4080219 IT WAS REPORTED BY CUSTOMER THAT THE 50ML SYRINGES AS BOTH SITES HAVE REPORTED RECEIVING SYRINGES WITHOUT CORRECT LABELING DOSAGE NUMBERS AND LINES ON THE SYRINGES. IT IS THE SAME LOT # FOR EACH LOCATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED SWWI AND FAIRMONT HAVE RECEIVED A BAD LOT OF 50ML SYRINGES AS BOTH SITES HAVE REPORTED RECEIVING SYRINGES WITHOUT CORRECT LABELING DOSAGE NUMBERS AND LINES ON THE SYRINGES. IT IS THE SAME LOT # FOR EACH LOCATION. 50 ML SYRINGE LUER-LOK ITEM # 309653 LOT# 4080219 WE WANTED TO BRING THIS TO YOUR ATTENTION AND ASK FOR A REPLACEMENT AND/OR REFUNDS TO EACH LOCATION AND PREVENT ANYMORE BAD PRODUCT TO BE SENT OUT. I BELIEVE BOTH SITES CURRENTLY ARE HOLDING ONTO THE ¿BAD PRODUCT¿ IF YOU WANT IT RETURNED. THANK YOU, XXXXXXXXXX

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? INDIRECTLY INVOLVED PATIENT/USER AS UNABLE TO USE PRODUCT. PLEASE CONFIRM THE NUMBER OF OCCURRENCES. EVENT OCCURRED TWICE IN (B)(6) BEFORE COMPLETE INVENTORY REVIEWED FOR ADDITIONAL STOCK WITH NOTED ISSUES. FIRST TIME EVENT OCCURRED PRODUCT WAS THROWN AS THOUGHT TO BE A ONE-OFF EVENT. SYRINGES EITHER HAD NO MARKINGS ON THEM, OR SYRINGES WERE MISSING SOME OF THE MARKINGS. MATERIAL #:309653. BATCH#:4080219. IT WAS REPORTED BY CUSTOMER THAT THE 50ML SYRINGES AS BOTH SITES HAVE REPORTED RECEIVING SYRINGES WITHOUT CORRECT LABELING DOSAGE NUMBERS AND LINES ON THE SYRINGES. IT IS THE SAME LOT # FOR EACH LOCATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. (B)(6) HAVE RECEIVED A BAD LOT OF 50ML SYRINGES AS BOTH SITES HAVE REPORTED RECEIVING SYRINGES WITHOUT CORRECT LABELING DOSAGE NUMBERS AND LINES ON THE SYRINGES. IT IS THE SAME LOT # FOR EACH LOCATION. 50 ML SYRINGE LUER-LOK ITEM # 309653. LOT# 4080219. WE WANTED TO BRING THIS TO YOUR ATTENTION AND ASK FOR A REPLACEMENT AND/OR REFUNDS TO EACH LOCATION AND PREVENT ANYMORE BAD PRODUCT TO BE SENT OUT. I BELIEVE BOTH SITES CURRENTLY ARE HOLDING ONTO THE ¿BAD PRODUCT¿ IF YOU WANT IT RETURNED. THANK YOU, XXXXXXXXXX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257628 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4080219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown