BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL 7.6L YEL AU NON-VENTED CAP

    MDR report key: 9900545 · Received March 30, 2020

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    Report

    Report Number
    2243072-2020-00525
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    March 5, 2020
    Report Date
    July 16, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 3/19/2020 H.6. INVESTIGATION: MANUFACTURING WAS NOT CONFIRMED BY THE POSSIBLE BD VENDORS, KELPEN PLASTICS OR FLEXTRONICS. A SAMPLE WAS RETURNED TO VH FOR EVALUATION BUT COULD NOT BE FORWARDED FOR FURTHER EVALUATION BY THE SUPPLIER. SUPPLIER FLEX WAS NOT ABLE TO CONFIRM MANUFACTURING. SUPPLIER KELPEN PROVIDED NO RESPONSE. A SAMPLE WAS PROVIDED AND THE ISSUE WAS CONFIRMED BY VERNON HILLS DCHU. HOWEVER NO FURTHER EVALUATION FOR THE SAMPLE COULD BE PROVIDED BY THE SUPPLIER. THE ISSUE COULD POSSIBLY OCCUR DURING THE MANUFACTURING PROCESS, BUT THERE WAS NOT ANY EVIDENCE PRODUCED BY THE SUPPLIER FOR THIS PRODUCT AS THE MANUFACTURER COULD NOT CONFIRM IT. THE LID ISSUE COULD BE CAUSED BY LOGISTIC HANDLING (TRANSPORTATION, STORAGE, DISTRIBUTION) OR REPACKAGING. UNFORTUNATELY, THE ROOT CAUSE COULD NOT BE CONFIRMED THROUGH ANY SUPPLIER INVESTIGATION. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHARPS COLL 7.6L YEL AU NON-VENTED CAP LID WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LID TO SHARP MALFORMED SHARPS BIN RECEIVED WITH HAVING INCOMPLETE LID"

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS HDQ US (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHARPS COLL 7.6L YEL AU NON-VENTED CAP LID WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LID TO SHARP MALFORMED. SHARPS BIN RECEIVED WITH HAVING INCOMPLETE LID."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365286 SHARPS COLL 7.6L YEL AU NON-VENTED CAP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 9G801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other