BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 27GA 1-1/2IN

    MDR report key: 8833662 · Received July 26, 2019

    Report

    Report Number
    1911916-2019-00739
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 9, 2019
    Report Date
    July 16, 2019
    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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE (1) PHOTO WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTO SHOWS A PICTURE OF A BOX LABEL ALONG WITH A COPY OF THE PACKING SLIP. THE BOX LABEL GIVES AN EXPIRATION DATE OF 2024-06-29 AND THE PACKING SLIP SHOWS A EXPIRATION DATE OF 2/29/2024. BASED ON THE PHOTO PROVIDED BY THE CUSTOMER AND THE PRODUCTION DATE IN THE BATCH RECORD BD ACKNOWLEDGES THAT THE PACKING SLIP HAS THE WRONG EXPIRATION DATE ON IT. 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. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LABEL CONTENT INCORRECT FOR LOT #9030562 ITEM #301629. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCHES ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEW DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. THE DHR REVIEW REVEALED THAT THE BATCH WAS PACKAGED ON 10-06-2019. ROOT CAUSE DESCRIPTION: BASED ON THE PHOTO PROVIDED BY THE CUSTOMER AND THE PRODUCTION DATE IN THE BATCH RECORD BD ACKNOWLEDGES THAT THE PACKING SLIP HAS THE WRONG EXPIRATION DATE ON IT. RATIONALE: BD ACKNOWLEDGES THAT BASED ON THE PHOTO PROVIDED BY THE CUSTOMER AND THE PRODUCTION DATE IN THE BATCH RECORD BD ACKNOWLEDGES THAT THE PACKING SLIP HAS THE WRONG EXPIRATION DATE ON IT. AS THE EXPIRATION DATE IS CORRECT ON THE BOX NO CORRECTIVE OR PREVENTATIVE ACTION IS PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE 27GA 1-1/2IN EXPERIENCED AN INCORRECT EXPIRATION DATE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301629, BATCH NO. 9030562. COMPLAINT 2 OF 2. THE PACKING SLIP FOR ITEM 301629 LOT# 9030562 HAS AN EXPIRATION OF 02/29/2024 BUT THE BOX IS PRINTED WITH 6/29/2024. EMAIL 7/10/2019: THE CASE WAS FOUND ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623789 NEEDLE 27GA 1-1/2IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9030562 30382903016298

    Patients

    Seq Age Sex Outcome Treatment
    1 Other