BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 10251761 · Received July 9, 2020

    Report

    Report Number
    1911916-2020-00636
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    June 17, 2020
    Report Date
    July 10, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO WAS PROVIDED FOR EVALUATION. IT SHOWS A PACKAGING BOX LABEL WITH 60 ML AND LOT# 8165956 AND SHOWS ANOTHER BOX LABEL OF 50 ML LOT# 9240280. ADDITIONALLY, IT SHOWS TWO PACKAGING BLISTERS ONE 60 ML AND ANOTHER ONE 50 ML. FROM THE PHOTOS, WE CAN CONCLUDE THAT THE CUSTOMER HAS A BOX(ES) LABELED AS 60 ML WITH PRODUCT 60 ML FROM THE LOT 8165956; THE CUSTOMER ALSO HAS A BOX(ES) LABELED AS 50 ML WITH 50 ML SYRINGES LOT# 9240280. BASED ON THE PHOTOS PROVIDED, WE CONCLUDE THAT AT A CERTAIN POINT OF THE SUPPLY CHAIN BOXES WITH 50 ML AND 60 ML SYRINGES WERE PUT TOGETHER. THE MANUFACTURING SITE IS RULED OUT SINCE THESE LOTS WERE PRODUCED WITH OVER A YEAR APART FROM EACH OTHER. IT IS UNKNOWN WHERE IT COULD HAVE HAPPENED. BASED ON THE INVESTIGATION AND WITH THE PHOTO PROVIDED, THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LABELS ON PACKAGES SAY 60ML AND OTHERS HAVE 50ML WITH A BD 60ML SYRINGE LUER-LOK¿ TIP. THIS OCCURRED ON 15 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SOME PACKAGE LABELS HAVE 60ML AND OTHERS HAVE 50ML.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LABELS ON PACKAGES SAY 60ML AND OTHERS HAVE 50ML WITH A BD 60ML SYRINGE LUER-LOK¿ TIP. THIS OCCURRED ON 15 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SOME PACKAGE LABELS HAVE 60ML AND OTHERS HAVE 50ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719152 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 9240280 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other