BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALCOHOL SWABS

    MDR report key: 18717059 · Received February 15, 2024

    Report

    Report Number
    1920898-2024-00064
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 29, 2024
    Report Date
    March 1, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR PR#(B)(4). HOWEVER, THIS COMPLAINT REPORT IS LINKED TO PR (B)(4) AND PHOTOS WERE PROVIDED FOR PR#(B)(4). THIS IS THE 2ND COMPLAINT FOR THE REPORTED LOT NUMBER 3024034, 3024036 AND THE 1ST FOR LOT NUMBER 3075747. EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER-INDICATED ISSUE ON PR (B)(4). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3024034. D4. MEDICAL DEVICE EXPIRATION DATE: 31DEC2027. H4. DEVICE MANUFACTURE DATE: 24JAN2023. D4. MEDICAL DEVICE LOT #: 3024036. D4. MEDICAL DEVICE EXPIRATION DATE: 31DEC2027. H4. DEVICE MANUFACTURE DATE: 24JAN2023. D4. MEDICAL DEVICE LOT #: 3075747. D4. MEDICAL DEVICE EXPIRATION DATE: 29FEB2028. H4. DEVICE MANUFACTURE DATE: 16MAR2023. H.3. 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 THAT THE BD ALCOHOL SWABS WERE LABELED INCORRECTLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE CUSTOMER REPORTS THAT THE SANITARY REGISTRATION OF THE SKU IS 326899 ERRONEOUS, IT READS 74892 SSA AND SHOULD READ 74982 SSA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALCOHOL SWABS WERE LABELED INCORRETLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE CUSTOMER REPORTS THAT THE SANITARY REGISTRATION OF THE SKU IS 326899 ERRONEOUS, IT READS 74892 SSA AND SHOULD READ 74982 SSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628583 BD ALCOHOL SWABS HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown