BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 20722810 · Received November 19, 2024

    Report

    Report Number
    1911916-2024-00818
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    November 5, 2024
    Report Date
    November 21, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP IT WAS REPORTED THE BLACK RUBBER PLUNGER STARTED TO LEAK. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, FIVE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE WITH 20ML OF A SOLUTION AND A PACKAGING BLISTER NEXT TO IT. THERE ARE DRIED DROPLETS OF SOLUTION BETWEEN THE SYRINGE RUBBER STOPPER RIBS AND PAST THE RUBBER STOPPER. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 4183160. 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. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MATERIAL # (B)(4) BATCH # 4183160. IT WAS REPORTED BY CUSTOMER THAT THE BLACK RUBBER PLUNGER STARTED TO LEAK AND THE MEDICATION STARTED TO LEAK DOWN THE INSIDE OF THE SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA COMMUNITY. PIR ATTACHED. WAS GOING TO DRAW UP CHEMO BEADS FOR A PATIENT DOSE AND THE BLACK RUBBER PLUNGER STARTED TO LEAK AND THE MEDICATION STARTED TO LEAK DOWN THE INSIDE OF THE SYRINGE. WE HAD TO WASTE THE MEDICATION AND RESCHEDULE THE SURGERY BECAUSE IT WAS A SPECIAL ORDERED MEDICATION. WE ARE REQUESTING THAT THE COST OF THE BEADS BE REIMBURSED. THE TOTAL OF THE BEADS IS (B)(4) DOLLARS. I AM WILLING TO PROVIDE PICTURES OF THE INCIDENT AND A PICTURE OF THE PRODUCT THAT WE HAD TO WASTE DUE TO SYRINGE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57162 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4183160 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown