BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL CULTURE SWAB PLUS MINI CHIP

    MDR report key: 12741233 · Received November 2, 2021

    Report

    Report Number
    9616066-2021-52354
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 5, 2021
    Report Date
    December 23, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    LIO
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE COMPLAINT IS FOR MATERIAL NUMBER 212554, BATCH NUMBER 201652300 FOR FM ISSUE. THE MANUFACTURER PERFORMED THE INVESTIGATION. THE MANUFACTURER CHECKED THE PHOTO AND CONFIRMED THE INCIDENT AS REPORTED. BASED ON THE DEFECT DESCRIPTION, AS WELL AS ON THE KNOWLEDGE OF THE CAP PRODUCTION PROCESS, IT IS REASONABLE TO SUPPOSE THAT THE REPORTED DEFECTS COULD BE PLASTIC WHICH BURNT DUE TO ITS PROLONGED PERMANENCE INTO THE HOT MOULD. BY DHR REVIEW, TWO ANOMALIES WERE REPORTED BY THE OPERATORS, RELATED TO TWO BLACKOUT EVENTS WHICH CAN CAUSE A LONGER TIME OF PERMANENCE OF PLASTIC RESIN INTO THE MOULD. BASED ON THE INVESTIGATION, THE MISSING COMPONENT IS CONSIDERED TO BE DUE TO PACKAGING MACHINE SETTING. THE MANUFACTURER WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BBL CULTURE SWAB PLUS MINI CHIP CHARCOAL (MEDICAL DEVICE), THE DEVICE EXPERIENCED CONTAMINATION - BIOLOGICAL CONTAMINATION - BACTERIAL, FUNGAL, NON-VIABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER FOUND BROWN FOREIGN MATTER RESEMBLING MOLD ON THE CAP OF THE SWAB.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BBL CULTURE SWAB PLUS MINI CHIP CHARCOAL (MEDICAL DEVICE), THE DEVICE EXPERIENCED CONTAMINATION BIOLOGICAL CONTAMINATION BACTERIAL, FUNGAL, NON-VIABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER FOUND BROWN FOREIGN MATTER RESEMBLING MOLD ON THE CAP OF THE SWAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632834 BD BBL CULTURE SWAB PLUS MINI CHIP SPECIMEN COLLECTION DEVICE LIO SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 201652300

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown