BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 20084986 · Received August 28, 2024

    Report

    Report Number
    1911916-2024-00631
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    May 9, 2024
    Report Date
    September 5, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: IT WAS REPORTED THERE WAS A FREE-FLOATING PARTICLE WAS DETECTED IN THE FINAL PRODUCT BAG. 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 DARK COLORED PARTICLE IN A PLASTIC BAG WITH SOLUTION. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 3209749. 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. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    MATERIAL: 302832. BATCH#: 3209749. IT WAS REPORTED BY THE CUSTOMER THAT DURING DENDREON¿S DAY 2 MANUFACTURING, A FREE-FLOATINGPARTICLE WAS DETECTED IN THE FINAL PRODUCT BAG, LEADING TO A LOT TERMINATION. THE PROCESS WAS MAPPED TO IDENTIFY POTENTIAL SOURCES. A 30ML SYRINGE FROM BECTONDICKINSON (BD) LOT 3209749, CONNECTED TO THE FINAL PRODUCT BAG VIA A THREE-WAY STOPCOCK, WAS SUSPECTED. DENDREON SUPPLIER QUALITY SHIPPED THE ISOLATED PARTICLE, ALONG WITH 30ML SYRINGE BLACK PLUNGER TO EUROFI NS EAG LABORATORIES FOR IDENTIFICATION BY FOURIER TRANSFORM INFRARED (FTIR) SPECTROMETER. THE EVALUATION DETERMINED THE BLACK PARTICLE WAS CHARACTERIZED AS POLYPROPYLENE AND SILICONE. THE SYRINGE SAMPLE WAS IDENTIFIED AS A SIMILAR, POLYPROPYLENE AND SILICON COMPOUND, BUT NOT AN IDENTICAL MATCH. THE 30ML SYRINGE PLUNGER MOST CLOSELY RESEMBLES THE PARTICLE OBSERVED IN THIS NONCONFORMANCE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 1. KINDLY PROVIDE THE DATE OF EVENT. MAY 9, 2024. 2. CAN YOU SHARE ANY PHYSICAL SAMPLE IF AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? (B)(4) SUPPLIER QUALITY SHIPPED THE ISOLATED PARTICLE, ALONG WITH 30ML SYRINGE BLACK PLUNGER TO (B)(6) LABORATORIES FOR IDENTIFICATION BY FOURIER TRANSFORM INFRARED (FTIR) SPECTROMETER. THE EVALUATION DETERMINED THE BLACK PARTICLE WAS CHARACTERIZED AS POLYPROPYLENE AND SILICONE AND ITS SIZE WAS ESTIMATED TO BE ~ 2479 BY 270. THE SYRINGE SAMPLE WAS IDENTIFIED AS A SIMILAR, POLYPROPYLENE AND SILICON COMPOUND, BUT NOT AN IDENTICAL MATCH. THE 30ML SYRINGE PLUNGER MOST CLOSELY RESEMBLES THE PARTICLE OBSERVED IN THIS NONCONFORMANCE. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. THE LOT WAS TERMINATED IN MANUFACTURING. 4.IF POSSIBLE, COULD YOU PLEASE PROVIDE PICTURE SAMPLES FOR INVESTIGATION? RETRIEVING PHOTO AND WILL FORWARD ACCORDINGLY. 5. PLEASE CONFIRM WHETHER THE BLACK PARTICLES FOUND INSIDE THE SYRINGE OR OUTSIDE THE SYRINGE. A FREE-FLOATING PARTICLE WAS DETECTED IN THE FINAL PRODUCT BAG. ADDITIONAL INFO: THERE ARE NO PHYSICAL SAMPLES AVAILABLE TO SEND TO BD. THE PARTICLE WAS ISOLATED AND SENT OUT TO A THIRD PARTY FOR ANALYSIS HENCE THE FEEDBACK DETAIL IN THE SCAR. LET ME KNOW IF ADDITIONAL DETAILS ARE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128239 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON 3209749 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown