BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 21G 1IN TW

    MDR report key: 10639299 · Received October 6, 2020

    Report

    Report Number
    8041187-2020-00645
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    September 15, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE CE MARK NUMBER ON THE SHELF CARTON AND CASE LABEL SHOWED CE2797 AND THE CE MARK NUMBER ON THE TOP WEB SHOWS CE0086 WHICH BELONGS TO THE OLD GRAPHICS. BASED ON THE INVESTIGATION AND THE DEVICE HISTORY REVIEW OF MATERIAL NUMBER 302015 AND BATCH NUMBER 0087346, THE WRONG TOP WEB WAS POTENTIALLY USED FOR APPROXIMATELY THREE HOURS DURING PRODUCTION OF THIS BATCH. BASED ON THE DHR REVIEW, THE NEEDLE PRIMARY PACKAGING INSPECTION FORM SHOWS THE OLD TOP WEB GRAPHICS OF CE MARK NUMBER CE0086 AND TOP WEB GRAPHICS WITH CE MARK NUMBER CE2797 WAS USED TO PRODUCE THIS BATCH. FURTHER INVESTIGATION SHOWED THAT THE PRODUCTION TECHNICIAN MAY HAVE JOINED TOP WEB CE0086 WITH TOP WEB CE2797 AND COLLECTED SAMPLES FOR THE INSPECTION, BUT DID NOT NOTICE THAT THE WRONG TOP WEB WAS PASTED ON THE INSPECTION FORM. THE PROBABLE ROOT CAUSE OF THIS NON-CONFORMANCE IS LIKELY THAT THE OLD GRAPHICS WAS NOT MOVED TO THE RACK AND WAS LEFT IN THE PRODUCTION AREA, THE OLD GRAPHICS MATERIAL THAT WAS MOVED TO RACKING WAS LATER RETRIEVED DOWN AND ISSUED TO PRODUCTION, OR THE DHR REVIEW WAS NOT ABLE TO PICK UP THE GRAPHIC DIFFERENCES. A PROJECT, CAPA#1981221, WILL BE INITIATED TO IDENTIFY ALL POTENTIAL FAILURE MODES AND CONTROL POINTS TO ADDRESS THIS NON-CONFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 50,000 NEEDLES 21G 1IN TW EXPERIENCED INCORRECT LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CE NUMBER PRINTING ERROR ON BLISTER PACKAGING. CE2797 IS PRINTED ON THE OUTBOX,BUT INNER PACKAGE BY EA HAS TWO DIFFERENT CE NUMBER MIXED (CE0086 + CE2797). THIS IS ONE BATCH PRODUCT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 50,000 NEEDLES 21G 1IN TW EXPERIENCED INCORRECT LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CE NUMBER PRINTING ERROR ON BLISTER PACKAGING. CE2797 IS PRINTED ON THE OUTBOX,BUT INNER PACKAGE BY EA HAS TWO DIFFERENT CE NUMBER MIXED (CE0086 + CE2797). THIS IS ONE BATCH PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097578 NEEDLE 21G 1IN TW NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 0087346

    Patients

    Seq Age Sex Outcome Treatment
    1 Other