BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL BNS

    MDR report key: 9806010 · Received March 9, 2020

    Report

    Report Number
    1213809-2020-00172
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 10, 2020
    Report Date
    March 18, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO OF A LOOSE 10ML SYRINGE WITH APPROXIMATELY 5ML OF CLEAR FLUID INSIDE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A LARGE BROWN FOREIGN MATTER PARTICLE FLOATING IN THE PATH. IT APPEARED TO BE A PIECE OF CARDBOARD AND WAS LARGER THAN LEVEL 2 IN SIZE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MATERIAL HANDLING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9242216 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 10ML LL BNS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301029 BATCH NO: 9242216. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: "SYRINGE WITH FOREIGN OBJECT FLOATING IN SALINE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 10ML LL BNS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301029 BATCH NO: 9242216. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: "SYRINGE WITH FOREIGN OBJECT FLOATING IN SALINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267920 SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9242216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other