BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GASPAK¿ CO2 INDICATORS

    MDR report key: 12978267 · Received December 10, 2021

    Report

    Report Number
    1119779-2021-01945
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    November 15, 2021
    Report Date
    November 23, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    KZJ
    UDI-DI
    30382902710555
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO SERVES TO SUMMARIZE FINDINGS ON RECENT COMPLAINT ON PRODUCT 271055, LOT NUMBER B01D260M WHERE IT WAS REPORTED THE PRODUCT LABEL HAS AN EXPIRATION OF 08-31-2024 AND A CERTIFICATE OF 08-28-2024. THE LABEL WAS CONFIRMED TO BE CORRECT PER THE BATCH HISTORY RECORD; THEREFORE THE CERTIFICATE WAS UPDATED WITH THE CORRECT EXPIRATION DATE OF 08-31-2024. THE MATTER WAS INVESTIGATED, AND A QUALITY NOTIFICATION WAS INITIATED. BASED UPON THIS INFORMATION, THE COMPLAINT IS CONFIRMED. A REVIEW OF PAST COMPLAINTS ON THIS PRODUCT OVER THE PAST 12 MONTHS YIELDED NO TREND SEEN FOR THIS ISSUE AS OF (B)(6) 2021. HOWEVER, BD WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDING. THE REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED WITH NO ISSUE BEING NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD GASPAK¿ CO2 INDICATORS INCORRECT LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EXPIRY ON PRODUCT DOES NOT MATCH CERTIFICATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871973 BD GASPAK¿ CO2 INDICATORS DEVICE, GAS GENERATING KZJ BECTON, DICKINSON & CO. (SPARKS) 271055 B01D260M 30382902710555

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown