BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARP CONTAINER LIDS

    MDR report key: 11529810 · Received March 19, 2021

    Report

    Report Number
    2243072-2021-00841
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 22, 2021
    Report Date
    May 12, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    MMK
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: WITHOUT ANY FURTHER INFORMATION PROVIDED LIKE A MATERIAL NUMBER FOR PRODUCT, A PHOTO, OR A SAMPLE, THE INVESTIGATION COULD NOT BE CONDUCTED AND VERY LIMITED INFORMATION IS AVAILABLE. THE CUSTOMER STATED THAT THE SETTING ON THE AUTOCLAVE WAS THE ISSUE WITH THIS FAILURE BUT WE DO NOT RECOMMEND THE USE OF THE AUTOCLAVE AT ANY TIME WHEN USING OUR SHARPS CONTAINERS. THERE ARE VERY FEW INSTANCES WHEN THIS IS CONDUCTED AND ONLY WHEN THE WHOLE CONTAINER IS BEING DISPOSED OF COMPLETELY AS IT COMES STERILE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHARP CONTAINER LIDS MELTED AFTER AUTOCLAVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN, BATCH NO: UNKNOWN. IT WAS REPORTED LIDS ON THE SHARPS CONTAINERS MELT WHEN THEY WERE BEING AUTOCLAVED. VERBATIM: PER CUSTOMER'S RESPONSE ON 03/02/2021. THANK YOU FOR YOUR RESPONSE. THE ISSUE WAS WITH THE PARTICULAR AUTOCLAVE SETTINGS AND NOT WITH THE SHARPS CONTAINER ITSELF. I AM CONTACTING YOU IN REGARDS TO THE BD RECYKLEE 19-GAL. SHARPS CONTAINERS OUR INSTITUTE PRIMARILY USES TO DISPOSE OF SHARPS. WE AUTOCLAVE EVERYTHING THAT COMES OUT OF OUR INSTITUTE, WE¿VE HAD A COUPLE OF THE LIDS ON THE SHARPS CONTAINERS MELT WHEN THEY WERE BEING AUTOCLAVED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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. 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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHARP CONTAINER LIDS MELTED AFTER AUTOCLAVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN. BATCH NO: UNKNOWN. IT WAS REPORTED LIDS ON THE SHARPS CONTAINERS MELT WHEN THEY WERE BEING AUTOCLAVED. VERBATIM: PER CUSTOMER'S RESPONSE ON (B)(6) 2021. THANK YOU FOR YOUR RESPONSE. THE ISSUE WAS WITH THE PARTICULAR AUTOCLAVE SETTINGS AND NOT WITH THE SHARPS CONTAINER ITSELF. I AM CONTACTING YOU IN REGARDS TO THE BD RECYKLEE 19-GAL. SHARPS CONTAINERS OUR INSTITUTE PRIMARILY USES TO DISPOSE OF SHARPS. WE AUTOCLAVE EVERYTHING THAT COMES OUT OF OUR INSTITUTE, WE¿VE HAD A COUPLE OF THE LIDS ON THE SHARPS CONTAINERS MELT WHEN THEY WERE BEING AUTOCLAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423444 SHARP CONTAINER LIDS SHARPS CONTAINER MMK BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1