BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ALLERGY SYRINGE WITH NEEDLE, TRAY

    MDR report key: 7781825 · Received August 14, 2018

    Report

    Report Number
    1920898-2018-00608
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    July 24, 2018
    Report Date
    September 25, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903055365
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (7000) 1/2CC, 27G BD ALLERGY SYRINGES IN SEALED TRAYS IN THE SHIPPING CARTON FROM LOT # 7073684 AND (1000) 1/2CC, 27G BD ALLERGY SYRINGES IN SEALED TRAYS IN THE SHIPPING CARTON FROM LOT # 6351901. CUSTOMER STATES THAT THEY HAVE THE CORRECT SYRINGES, BUT LABEL ON THE SYRINGE BOX WAS INCORRECT. ALL RETURNED TRAYS WERE EXAMINED AND ALL EXHIBITED ¿TREATMENT¿ PRINTED ON THE TRAY COVER. THE SHIPPING CARTONS WERE ALSO EXAMINED AND ALL EXHIBITED ¿TESTING¿ PRINTED ON THE LABEL. CAPA (B)(4) AND SITUATION ANALYSIS MSS-17-1005-SA HAS BEEN OPENED TO ADDRESS THIS ISSUE. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGES IN THE BOX OF BD ALLERGY TRAY PRECISIONGLIDE¿ ATTACHED NEEDLE WERE IN QUESTION. THE LABEL ON BOXES DOES NOT MATCH THE PRODUCT INSIDE THE BOX. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGES IN THE BOX OF BD ALLERGY TRAY PRECISIONGLIDE¿ ATTACHED NEEDLE WERE IN QUESTION. THE LABEL ON BOXES DOES NOT MATCH THE PRODUCT INSIDE THE BOX. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7073684 , MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: 2017-03-14. MEDICAL DEVICE LOT #: 6351901, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE: 2016-12-16. 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 · 1

    IT WAS REPORTED THAT THE SYRINGES IN THE BOX OF BD ALLERGY TRAY PRECISIONGLIDE¿ ATTACHED NEEDLE WERE IN QUESTION. THE LABEL ON BOXES DOES NOT MATCH THE PRODUCT INSIDE THE BOX. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621022 BD¿ ALLERGY SYRINGE WITH NEEDLE, TRAY SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE SEE H.10 30382903055365

    Patients

    Seq Age Sex Outcome Treatment
    1 Other