BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 19971841 · Received August 13, 2024

    Report

    Report Number
    1911916-2024-00588
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    August 7, 2024
    Report Date
    August 29, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THE PLUNGER HAS VISIBLE PARTICULATE MATTER. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE PLUNGER ROD THUMB PRESS HAS A SPECK OF EMBEDDED DEGRADED RESIN. THE THREE PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 4122453. 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 SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND 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; BATCH#:4122453. IT WAS REPORTED BY CUSTOMER THAT THEY NOTICED TODAY UPON REMOVING A STERILE 30ML SYRINGE, THE PLUNGER HAS VISIBLE PARTICULATE MATTER. DUE TO THE POTENTIAL CONTAMINATION HINDERING STERILITY, THIS SYRINGE WAS NOT USED. RCC RECEIVED A COMPLAINT VIA EMAIL. OUR TEAM MEMBER NOTICED TODAY UPON REMOVING A STERILE 30ML SYRINGE, THE PLUNGER HAS VISIBLE PARTICULATE MATTER. DUE TO THE POTENTIAL CONTAMINATION HINDERING STERILITY, THIS SYRINGE WAS NOT USED. SYRINGE IS AVAILABLE TO BE SENT FOR FURTHER INVESTIGATION. IF YOU WOULD LIKE US TO SEND THE SYRINGE FOR REVIEW PLEASE EMAIL US. ITEM -302832. LOT - 4122453.

    Description of Event or Problem · 0

    MATERIAL #:302832 BATCH#:4122453. IT WAS REPORTED BY CUSTOMER THAT THEY NOTICED TODAY UPON REMOVING A STERILE 30ML SYRINGE, THE PLUNGER HAS VISIBLE PARTICULATE MATTER. DUE TO THE POTENTIAL CONTAMINATION HINDERING STERILITY, THIS SYRINGE WAS NOT USED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. OUR TEAM MEMBER NOTICED TODAY UPON REMOVING A STERILE 30ML SYRINGE, THE PLUNGER HAS VISIBLE PARTICULATE MATTER. DUE TO THE POTENTIAL CONTAMINATION HINDERING STERILITY, THIS SYRINGE WAS NOT USED. SYRINGE IS AVAILABLE TO BE SENT FOR FURTHER INVESTIGATION, SEE ATTACHED PICTURES. IF YOU WOULD LIKE US TO SEND THE SYRINGE FOR REVIEW, PLEASE EMAIL US A SHIPPING LABEL TO: XXXXXXXXXXXX. ITEM -302832. LOT - 4122453.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163778 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON 4122453 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown