BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE

    MDR report key: 8383649 · Received March 1, 2019

    Report

    Report Number
    9617032-2019-00246
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 21, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    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

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER, STATING THAT "THE CODE THAT THE CUSTOMER USUALLY RECEIVES IS 360213, HOWEVER THE DISTRIBUTOR SENT THE CATALOG 360212 AND THIS IS ALREADY CLEAR TO THE CUSTOMER. IN THIS WAY THE NEEDLE ABOUT THE CATALOG 360212 IS SHORTER THAN 360213 CATALOG." THIS CLASSIFIES THE COMPLAINT AS A GENERAL DISSATISFACTION, WHICH RENDERS THE COMPLAINT NON-REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 30 OF THE BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLES WERE OBSERVED DURING USE TO BE SHORTER THAN THE SAME PRODUCT FROM DIFFERENT LOT NUMBERS. AS REPORTED BY THE CUSTOMER, TRANSLATED FROM SPANISH TO ENGLISH, "NEEDLES OF LOT 8110903 ARE SHORTER IN LENGTH THAN THOSE OF DIFFERENT LOTS, 30 UNITS. SHORT NEEDLES CAUSE DISCOMFORT AT THE TIME OF SAMPLING."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 30 OF THE BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLES WERE OBSERVED DURING USE TO BE SHORTER THAN THE SAME PRODUCT FROM DIFFERENT LOT NUMBERS. AS REPORTED BY THE CUSTOMER, TRANSLATED FROM SPANISH TO ENGLISH, "NEEDLES OF LOT 8110903 ARE SHORTER IN LENGTH THAN THOSE OF DIFFERENT LOTS, 30 UNITS. SHORT NEEDLES CAUSE DISCOMFORT AT THE TIME OF SAMPLING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174199 BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE BLOOD COLLECTION NEEDLE FMI BECTON, DICKINSON AND COMPANY (BD) 8110903

    Patients

    Seq Age Sex Outcome Treatment
    1 Other