BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CAP DISINFECTION SINGLES CE

    MDR report key: 12721125 · Received October 29, 2021

    Report

    Report Number
    1911916-2021-01118
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    September 29, 2021
    Report Date
    November 8, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    QBP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: IT WAS REPORTED NON-CONFORMITIES HAVE BEEN FOUND REGARDING THE LABEL. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A CASE BOX AND THE CASE LABEL. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. ALL THE GRAPHICS ARE ACCORDING TO THE PRODUCT SPECIFICATIONS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306598, LOT NUMBER 0279483. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CAP DISINFECTION SINGLES CE HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NON-CONFORMITIES HAVE BEEN FOUND, REGARDING THE LABEL".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CAP DISINFECTION SINGLES CE HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NON-CONFORMITIES HAVE BEEN FOUND, REGARDING THE LABEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615413 BD CAP DISINFECTION SINGLES CE NA QBP BD MEDICAL (BD WEST) MEDICAL SURGICAL 0279483

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown