BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL 6GAL RED 1103 NON-VENT CAP

    MDR report key: 8600709 · Received May 10, 2019

    Report

    Report Number
    2243072-2019-00900
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 25, 2019
    Report Date
    June 19, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903054577
    PMA / PMN Number
    K943134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR: ACCORDING TO THE DHR REVIEW PROCESS; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE MISSING LIDS, LID BROKEN AND LID CLOSED DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER REPORTED UNDER THIS CUSTOMER COMPLAINT. INVESTIGATION ACCORDING WITH THE COMPLAINT REPORT AND PICTURES PROVIDED, SEVERAL DAMAGES AND MISSING LIDS WERE FOUND ON THE CONTAINER ORDERED BY THE CUSTOMER. AS PER COMPLAINT PROBLEM DESCRIPTION, THE CONTAINER WAS ORDERED THROUGH DISTRIBUTOR HENRY SCHEIN WHICH IN PREVIOUS INVESTIGATIONS IT WAS CONFIRMED THAT THEY ARE PERFORMING AN ADDITIONAL REPACKAGING TO PERFORM PARTIAL SALES WHEN FLEX IS USING A STANDARD PACK REQUIRED BY BECTON DICKINSON WITHIN THE BUY SPECIFICATIONS. DUE TO EVIDENCE FROM ORIGINAL BOX WAS NOT PROVIDED BY CUSTOMER, IT WAS CONCLUDED THAT THERE IS NO ENOUGH EVIDENCE TO DETERMINE THE ROOT CAUSE OF THIS ISSUE SINCE THESE KINDS OF ISSUES COULD BE GENERATED DUE INCORRECT HANDLING AND/OR INCORRECT PACKAGING. POTENTIAL ROOT CAUSE: 1.NON-CONTROLLED METHOD TO PERFORM REPACKAGING. 2.PRODUCT DAMAGED DURING THE SHIPMENT OR DISTRIBUTION. 3.NOT SUITABLE PACKAGING USED TO SHIP PARTIAL SALES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 SHARPS COLL 6GAL RED 1103 NON-VENT CAP EXPERIENCED MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305457 BATCH NO: 8213927. EVENT DESCRIPTION PER ATTACHED EMAIL STATES, "4 LIDS MISSING - 305457 / BATCH # 8213927."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 SHARPS COLL 6GAL RED 1103 NON-VENT CAP EXPERIENCED MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305457, BATCH NO: 8213927. EVENT DESCRIPTION PER ATTACHED EMAIL STATES, "4 LIDS MISSING - 305457 / BATCH # 8213927".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391497 SHARPS COLL 6GAL RED 1103 NON-VENT CAP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 8213927 50382903054577

    Patients

    Seq Age Sex Outcome Treatment
    1 Other