BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 17738524 · Received September 13, 2023

    Report

    Report Number
    8041187-2023-00487
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 29, 2023
    Report Date
    September 25, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057581
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE 1 PHOTO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LABEL CONTENT INCORRECT WAS CONFIRMED UPON INSPECTION OF THE SAMPLE PHOTO. ANALYSIS OF THE SAMPLE PHOTO SHOWED THAT THE TOP WEB ARTWORK RELATED TO THE BD ECLIPSE BRAND NAME WAS CUT OFF. THE CANNULA GAUGE AND SIZE INFORMATION WERE ON THE LABEL, AS WELL AS THE VARIABLE PRINT INFORMATION. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS RELATED TO OUR MANUFACTURING PROCESS. ACTIONS HAVE BEEN TAKEN TO ADDRESS THIS ISSUE. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ECLIPSE¿ NEEDLE THE LABEL WAS MISSING INFORMATION. THIS OCCURRED ON 64800 PIECES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) HAS INFORMED ME THAT DURING THE APPEARANCE INSPECTION OF THE ECLIPSE NEEDLES BATCH 0010716410, VENDOR LOT 3083420 RECEIVED LAST WEEK. IT WAS NOTIFIED THAT THE TITLE ON THE BLISTER WAS PRINTED ON THE PERFORATION. WHICH MEANS THAT WHEN THE PACKS GET SEPARATED, SOME OF THE TEXT IS MISSING/UNREADABLE. IT WAS FOUND AROUND 20 PACKS FROM ONE BOX WITH THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ECLIPSE¿ NEEDLE THE LABEL WAS MISSING INFORMATION. THIS OCCURRED ON 64800 PIECES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AMGEN BREDA HAS INFORMED ME THAT DURING THE APPEARANCE INSPECTION OF THE ECLIPSE NEEDLES BATCH 0010716410, VENDOR LOT 3083420 RECEIVED LAST WEEK. IT WAS NOTIFIED THAT THE TITLE ON THE BLISTER WAS PRINTED ON THE PERFORATION. WHICH MEANS THAT WHEN THE PACKS GET SEPARATED, SOME OF THE TEXT IS MISSING/UNREADABLE. IT WAS FOUND AROUND 20 PACKS FROM ONE BOX WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615053 BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 3083420 30382903057581

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown