BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 19882119 · Received August 1, 2024

    Report

    Report Number
    1911916-2024-00558
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 14, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 THERE WAS A GEL-LIKE SUBSTANCE INSIDE THE STERILE TUBE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SILICONE IS VISIBLE INSIDE THE SYRINGE BARREL. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM WHEN THE SILICONE WAS BEING APPLIED TO THE SYRINGE BARREL INDUCING AN EXTRA AMOUNT OF SILICONE INTO THE SYRINGE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 4030300. 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 SYRINGE BARREL SILICONE APPLICATION PROCESS WAS PERFORMED. THE ALIGNMENT OF THE RAILS AND BARREL FEED WERE CORRECT. THE FLOW OF PRODUCT WAS GOOD. 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

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL #: 302832; BATCH#: 4030300. IT WAS REPORTED BY CUSTOMER THAT SYRINGE HAS GEL-LIKE SUBSTANCE INSIDE THE STERILE TUBE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. SYRINGE HAS GEL-LIKE SUBSTANCE INSIDE THE STERILE TUBE. CATALOG #: 302832; LOT #: 4030300.

    Description of Event or Problem · 0

    MATERIAL #: 302832 BATCH#: 4030300 IT WAS REPORTED BY CUSTOMER THAT SYRINGE HAS GEL-LIKE SUBSTANCE INSIDE THE STERILE TUBE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. SYRINGE HAS GEL-LIKE SUBSTANCE INSIDE THE STERILE TUBE. CATALOG #: 302832. LOT #: 4030300.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963519 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON 4030300 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown