BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 27GA 1-1/2IN

    MDR report key: 9993355 · Received April 23, 2020

    Report

    Report Number
    1911916-2020-00406
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    March 25, 2020
    Report Date
    April 16, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903016298
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED. IT SHOWS A PACKAGING BLISTER WITH THE LOT# AND THE EXPIRATION DATE AS OF 2024-06-29; THE COC THE CUSTOMER GOT FROM THE SYSTEM HAS EXPIRATION DATE OF 2024-02-29. THE PRODUCTION ORDERS ARE CREATED THE PREVIOUS MONTH THAN THE MONTH PLANNED TO BE PRODUCED; SOMETIMES THE PRODUCTION ORDER IS DELAYED AND PRODUCED AT LATER MONTH(S) THAN ORIGINALLY PLANNED. WHEN THE PRODUCTION ORDER IS PRODUCED THE EXPIRATION DATE IS CREATED/ PRINTED ON THE LABELING IS BASED ON THE ACTUAL MANUFACTURING MONTH. IN THIS CASE THE PRODUCTION PLANNING DIDN¿T UPDATE THE SYSTEM WITH THE EXPIRATION DATE BASED ON THE ACTUAL MANUFACTURING DATE. A REVISED COC WILL BE ISSUED TO THE CUSTOMER AND PRODUCTION PLANNING IS NOT ANYMORE CARRYING OVER FOR MONTH OPEN PRODUCTION ORDERS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: 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. ROOT CAUSE DESCRIPTION: PRODUCTION PLANNING- IN THIS CASE THE PRODUCTION PLANNING DIDN¿T UPDATE THE SYSTEM WITH THE EXPIRATION DATE BASED ON THE ACTUAL MANUFACTURING DATE. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 27GA 1-1/2IN HAD INCORRECT LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301629 BATCH NO: 9030562. IT WAS REPORTED THAT EXPIRATION DATE ON THE PACKAGE OF THE NEEDLE IS DIFFERENT FROM THE EXPIRATION DATE ON THE COC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456401 NEEDLE 27GA 1-1/2IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 301629 9030562 30382903016298

    Patients

    Seq Age Sex Outcome Treatment
    1 Other