BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SHARPS COLL¿ 5GAL RED SCREW CAP

    MDR report key: 8546189 · Received April 24, 2019

    Report

    Report Number
    2243072-2019-00780
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 9, 2019
    Report Date
    August 16, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903055772
    PMA / PMN Number
    K943139
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A SAMPLE WAS RETURNED AND PICTURE PROVIDED FOR EVALUATION WITH THE MANUFACTURER. THE CAP WAS CONFIRMED TO BE CRACKED. THE CAP SHOULD BE FULLY FORMED AND FUNCTION WITHOUT ANY DEFECTS. IN STOCK PRODUCT WAS CHECKED AND FOUND NO RELATED ISSUES. ALL PERSONNEL WAS NOTIFIED TO LOOK AT EACH CAP FOR PREVENTIVE ACTION. CAP WAS SEEN TO BE CRACKED BUT IT COULD NOT BE CONFIRMED IF THIS ISSUE HAS OCCURRED DURING SHIPPING. THE ROOT CAUSE WAS INCONCLUSIVE BUT THE ISSUE LIKELY OCCURRED DURING SHIPPING. WE HAVE REVIEWED COMPLAINT WITH ALL PERSONEL AND REVIEWED DHR WITH NO FINDINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRODUCT IS DAMAGED WITH A BD SHARPS COLL¿ 5GAL RED SCREW CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT IS DAMAGED/LEAKING/OUTDATED. PLEASE LET US KNOW IF A CALL TAG WILL BE ISSUED OR IF YOU WOULD LIKE US TO DESTROY OR DONATE THE PRODUCT.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER: ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. INITIAL REPORTER PHONE #: UNKNOWN. DEVICE EVALUATED BY MFR: 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 PRODUCT IS DAMAGED WITH A BD SHARPS COLL¿ 5GAL RED SCREW CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT IS DAMAGED/LEAKING/OUTDATED. PLEASE LET US KNOW IF A CALL TAG WILL BE ISSUED OR IF YOU WOULD LIKE US TO DESTROY OR DONATE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340479 BD SHARPS COLL¿ 5GAL RED SCREW CAP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 8347002 50382903055772

    Patients

    Seq Age Sex Outcome Treatment
    1 Other