BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 21755723 · Received April 2, 2025

    Report

    Report Number
    1911916-2025-00260
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 31, 2025
    Report Date
    April 9, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED A FEW PRIMARY PACKAGES HAD HOLES IN THEM. TO AID IN THE INVESTIGATION, TWO SAMPLES IN SEALED PACKAGING BLISTERS AND ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE PACKAGING BLISTER TOP WEB HAS A PIN HOLE. THE PHOTO PROVIDED SHOWS THE SAMPLES RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION OCCURS IF THE TOP WEB IS DAMAGED DURING LOADING. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 4243271. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    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

    MATERIAL#: 302832, LOT#: 4243271. IT WAS REPORTED BY CUSTOMER THAT RESTOCKING OUR STERILE 797 IV ROOM, THE TECH NOTICED THAT A FEW OF THE PRIMARY PACKAGING HAD HOLES IN THEM. THIS MAKES THE SYRINGES NO LONGER STERILE, THEREFORE WE ARE UNABLE TO USE THEM FOR COMPOUNDING. RCC RECEIVED A COMPLAINT VIA PHONE. APON RESTOCKING OUR STERILE 797 IV ROOM, THE TECH NOTICED THAT A FEW OF THE PRIMARY PACKAGING HAD HOLES IN THEM. THIS MAKES THE SYRINGES NO LONGER STERILE, THEREFORE WE ARE UNABLE TO USE THEM FOR COMPOUNDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688241 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON 4243271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown