BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 10899434 · Received November 25, 2020

    Report

    Report Number
    2243072-2020-01929
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    November 5, 2020
    Report Date
    December 11, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 UATION? YES. D10: RETURNED TO MANUFACTURER ON: (B)(6) 2020. H6: INVESTIGATION SUMMARY INSTRUMENT SEDI 40 00203 WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH RESPECT TO THE REPORTED DEFECT ¿ BROKEN INSTRUMENT COVER. THE INSTRUMENT WAS EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND TWO LOOSE SCREWS AND TWO MISSING SCREWS WERE FOUND THAT HOLD THE BACK PLATE IN PLACE. THE SCREWS WERE INSERTED AND RESEATED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BEDI-40 EXPERIENCED STOPPER POPS OUT OF THE TUBE AND BROKEN LID/CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED "AFTER INSERTING THE SAMPLE, THE LID OPENS AUTOMATICALLY DURING THE DETERMINATION AND THE TUBE POPS OUT. THIS DOES NOT HAPPEN EACH TIME. SOMETIMES IT HELPS TO SWITCH OFF AND ON. BROKEN INSTRUMENT COVER".

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 THE BEDI-40 EXPERIENCED STOPPER POPS OUT OF THE TUBE AND BROKEN LID/CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED "AFTER INSERTING THE SAMPLE, THE LID OPENS AUTOMATICALLY DURING THE DETERMINATION AND THE TUBE POPS OUT. THIS DOES NOT HAPPEN EACH TIME. SOMETIMES IT HELPS TO SWITCH OFF AND ON. BROKEN INSTRUMENT COVER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372084 BD SEDI-40 ESR INSTRUMENT JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1