BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 30ML LL S/C 56

    MDR report key: 19697484 · Received July 8, 2024

    Report

    Report Number
    1911916-2024-00480
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 14, 2024
    Report Date
    August 27, 2024
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED THERE IS A SUBSTANCE IN THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. FIRST, WITH 10X MAGNIFICATION, THEN WITH 30X MAGNIFICATION. THERE IS A PIECE OF PLASTIC ATTACHED TO THE SYRINGE RUBBER STOPPER THAT IS 3/16" IN SIZE. THE PIECE HAS THE APPEARANCE OF THE PLASTIC SIMILAR TO THAT OF THE PLUNGER ROD MATERIAL. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE ASSEMBLY PROCESS RESULTING IN DAMAGE TO A PLUNGER ROD AND PLASTIC ENDING UP IN THE SAMPLE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 4080899. 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. VERIFICATION OF THE ASSEMBLY PROCESS WAS PERFORMED. ALIGNMENT OF THE RAILS AND CONVEYORS WAS CORRECT. THE FLOW OF PRODUCT WAS GOOD. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE ISSUE WAS DISCOVERED BEFORE PATIENT USE. MATERIAL NUMBER: UNKNOWN; LOT NUMBER: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT THERE IS SOME SORT OF SUBSTANCE IN THE SYRINGE. RCC RECEIVED A COMPLAINT VIA EMAIL. I WORK AT AN INFUSION PHARMACY IN (B)(6). WE USE SOME OF YOUR SYRINGES IN COMPOUNDING MEDICATIONS, INCLUDING HAZARDOUS MEDICATIONS. WHILE COMPOUNDING A MVSAI WHEN THE MEDICATION WAS BEING PUSHED FROM THE SYRINGE INTO THE NS 0.9% BAG, IT WAS NOTICED THAT THERE WAS SOME SORT OF SUBSTANCE IN THE SYRINGE. I WANTED TO REACH OUT TO YOU REGARDING THIS. I DO STILL HAVE THE AFFECTED SYRINGE AS WELL. PLEASE REACH OUT TO ME WITH THE NEXT STEPS.

    Description of Event or Problem · 0

    MATERIAL NUMBER: UNKNOWN; LOT NUMBER: UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE 30ML LL S/C 56 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WORK AT AN (B)(6) PHARMACY IN (B)(6). WE USE SOME OF YOUR SYRINGES IN COMPOUNDING MEDICATIONS, INCLUDING HAZARDOUS MEDICATIONS. WHILE COMPOUNDING A MVSAI WHEN THE MEDICATION WAS BEING PUSHED FROM THE SYRINGE INTO THE NS 0.9% BAG, IT WAS NOTICED THAT THERE WAS SOME SORT OF SUBSTANCE IN THE SYRINGE. I WANTED TO REACH OUT TO YOU REGARDING THIS. I DO STILL HAVE THE AFFECTED SYRINGE AS WELL. PLEASE REACH OUT TO ME WITH THE NEXT STEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497739 BD SYRINGE 30ML LL S/C 56 PISTON SYRINGE FMF BECTON DICKINSON AND COMPANY 4080899 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown