BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARREL 3ML LL WWD WITH SIL NO LOGO BNS

    MDR report key: 9868584 · Received March 23, 2020

    Report

    Report Number
    1213809-2020-00198
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    March 3, 2020
    Report Date
    April 6, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : FOUR PHOTOS DISPLAYING LOOSE 3ML BARRELS WERE RECEIVED AND EVALUATED. ONE PHOTO DISPLAYED A BARREL WITH CONTACT SMEARS EXTENDING FROM THE MIDDLE OF THE BARREL TO UNDER THE STEP. ONE PHOTO DISPLAYED A BARREL WITH SIGNIFICANT DAMAGE AT THE FLANGE AND AT THE STEP AS WELL DEFORMATIONS NEAR THE TOP. TWO PHOTOS APPEARED TO BE IDENTICAL AND DISPLAYED A BARREL WITH AN UNDEFINED STEP AND NO TIP OR COLLAR PRESENT. THE CONTACT SMEARS, DAMAGE AND INCOMPLETE FILL WERE REJECTABLE PER PRODUCT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE FOR THE CONTACT SMEAR DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THE POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE POTENTIAL ROOT CAUSE FOR THE INCOMPLETE FILL DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. PHYSICAL SAMPLES OF EACH DEFECT WOULD BE HELPFUL FOR A MORE THOROUGH EVALUATION. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9214002 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, 6 BARREL 3ML LL WWD WITH SIL NO LOGO BNS WERE FOUND WITH CROOKED SCALE PRINT, AND 3 SYRINGES WERE FOUND WITH SHORT SHOT MOLDING DEFECTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOW WE'RE RECEIVING THE FOLLOWING COSMETIC DEFECTS. NONE OF THESE WERE REPORTED DURING INCOMING INSPECTION BUT FROM OUR PRODUCTION ASSOCIATES AT THE ASSEMBLY LINE. 6 EAS WITH CROOKED SCALE PRINTED. 3 UNITS WITH INCOMPLETE / SHORT SHOT MOLDING. AFFECTED P/N.: 012-2120410; VYAIRE LOT: 10000037471, BD LOT: (300157) 9214002."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 BEFORE USE, 6 BARREL 3ML LL WWD WITH SIL NO LOGO BNS WERE FOUND WITH CROOKED SCALE PRINT, AND 3 SYRINGES WERE FOUND WITH SHORT SHOT MOLDING DEFECTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOW WE'RE RECEIVING THE FOLLOWING COSMETIC DEFECTS. NONE OF THESE WERE REPORTED DURING INCOMING INSPECTION BUT FROM OUR PRODUCTION ASSOCIATES AT THE ASSEMBLY LINE. 6 EAS WITH CROOKED SCALE PRINTED. 3 UNITS WITH INCOMPLETE / SHORT SHOT MOLDING. AFFECTED P/N.: 012-2120410; VYAIRE LOT: 10000037471, BD LOT: (300157) 9214002."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334058 BARREL 3ML LL WWD WITH SIL NO LOGO BNS SYRINGE FMF BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9214002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other