BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL ASIA 13.2L YEL 1508 NON-VENT

    MDR report key: 11646272 · Received April 9, 2021

    Report

    Report Number
    2243072-2021-01090
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 12, 2021
    Report Date
    June 22, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    MMK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-03-24. INVESTIGATION SUMMARY: A SAMPLE REPRESENTATION WAS PROVIDED FOR THE COMPLAINT. A DHR REVIEW WAS PERFORMED AND SHOWED THERE WERE NO ISSUES REPORTED LIKE LID BROKEN ¿ DAMAGED DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER 0141946. A REVIEW OF NON-CONFORMING MATERIAL REPORT (NCMR) WAS PERFORMED FOR THIS PART FOR THE PAST 12 MONTHS AND NO ISSUES WERE REPORTED FOR LID BROKEN ¿ DAMAGED FOR THE SAME PART NUMBER. THE BROKEN CORNERS WERE OBSERVED ON SAMPLE PROVIDED. AS PART OF THIS INVESTIGATION THERE IS NOT ENOUGH INFORMATION PROVIDED LIKE PICTURES OF PACKAGING USED TO SEND MATERIAL TO THE END USER, IN ACCORDANCE WITH AVAILABLE INFORMATION. POTENTIAL ROOT CAUSES ARE INCORRECT HANDLING, PARTIAL SELLS, AND INADEQUATE PACKAGING BY DISTRIBUTOR. BD WILL CONTINUE TO MONITOR FOR ANY TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHARPS COLL ASIA 13.2L YEL 1508 NON-VENT WAS CRACKED. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED 3X 13L SHARP CONTAINER COVER THAT IS CRACKED.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHARPS COLL ASIA 13.2L YEL 1508 NON-VENT WAS CRACKED. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED 3X 13L SHARP CONTAINER COVER THAT IS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542992 SHARPS COLL ASIA 13.2L YEL 1508 NON-VENT SHARPS CONTAINER MMK BECTON DICKINSON 141946

    Patients

    Seq Age Sex Outcome Treatment
    1