BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MINIDRAW¿ FINGER SLEEVE, LARGE

    MDR report key: 19863274 · Received July 30, 2024

    Report

    Report Number
    2243072-2024-00835
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    July 1, 2024
    Report Date
    September 30, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GIM
    PMA / PMN Number
    K230391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS ROCHLING MEDICAL ROCHESTER. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3153001. D4. MEDICAL DEVICE EXPIRATION DATE: 02-DEC-2025. H4. DEVICE MANUFACTURE DATE: 06-FEB-2024. D4. MEDICAL DEVICE LOT #: 3152001. D4. MEDICAL DEVICE EXPIRATION DATE: 01-DEC-2025. H4. DEVICE MANUFACTURE DATE: 06-FEB-2024. D4. MEDICAL DEVICE LOT #: 3156001. D4. MEDICAL DEVICE EXPIRATION DATE: 07-DEC-2025. H4. DEVICE MANUFACTURE DATE: 06-FEB-2024. D2B. MEDICAL DEVICE TYPE: THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: JKA. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K230493. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL #: 366615. LOT/BATCH #: 3153001, 3152001, AND 3156001. BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR INCORRECT EXPIRATION DATE WITH THE INCIDENT LOT WAS OBSERVED. 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 ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE INCORRECT EXPIRATION DATE. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THE ISSUE OF INCORRECT EXPIRATION DATE VIA SITUATION ANALYSIS AND SUPPLIER SCAR. THE SCAR CONTAINS CORRECTIVE AND PREVENTIVE ACTIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING THE BD MINIDRAW¿ FINGER SLEEVE, LARGE THAT AN UNSPECIFIED NUMBER OF SLEEVES HAD AN EXPIRATION DATE BEYOND THE EXPECTED EIGHTEEN (18) MONTHS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING THE BD MINIDRAW¿ FINGER SLEEVE, LARGE THAT AN UNSPECIFIED NUMBER OF SLEEVES HAD AN EXPIRATION DATE BEYOND THE EXPECTED EIGHTEEN (18) MONTHS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187513 BD MINIDRAW¿ FINGER SLEEVE, LARGE BLOOD SPECIMEN COLLECTION DEVICE GIM BECTON DICKINSON SEE H11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown