BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 10840860 · Received November 13, 2020

    Report

    Report Number
    1911916-2020-01029
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1943691. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, 1 PHYSICAL AND 1 PICTURE SAMPLE WAS RECEIVED. THE SAMPLE CAME IN A SEALED PACKAGING BLISTER WITH THE NEEDLE ASSEMBLY IN IT AND HAS THE PLASTIC SHIELD. A VISUAL INSPECTION WAS PERFORMED; FIRST NAKED EYE AND AFTER WITH A 30X MICROSCOPE. THERE ARE BLACK PARTICLES ADHERED TO THE PACKAGING WEB - IT IS PARTICLES OF INK. THIS IS THE INK USED TO PRINT THE LOT NUMBER AND THE EXPIRATION DATE ON THE TOP WEB. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. INVESTIGATION CONCLUSION: OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS. ROOT CAUSE DESCRIPTION: THE CAUSE FOR THIS DEFECT COULD HAVE OCCURRED FROM A JAM IN THE PRINTER DURING THE PACKAGING PROCESS WHERE INK WAS RELEASED, CAUSING THE BLACK PARTICLES. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 30X1/2 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305106, BATCH NO: 8290968. IT WAS REPORTED THAT BLACK PARTICLES WERE OBSERVED WITHIN ONE OF THE INJECTION NEEDLE WRAPPERS. EVENT DESCRIPTION PER EMAIL STATES: ON (B)(6) 2020, DURING AN UNRELATED PRODUCT COMPLAINT INVESTIGATION A RETAINS EXAM AND COMPONENT EXAMINATION WAS PERFORMED AND BLACK PARTICLES WERE OBSERVED WITHIN ONE OF THE COMPONENT INJECTION NEEDLE WRAPPERS. THERE WAS A TOTAL OF 120 RETAIN SAMPLES INSPECTED WITH ONE KIT AFFECTED BY THIS DEFECT ASSOCIATED WITH INJECTION NEEDLE. AFFECTED ITEM WAS RETURNED TO QA RAW MATERIALS. THIS OBSERVATION IS NOT RELATED TO A PRODUCT COMPLAINT REPORTED. AS THIS IS DRUG PRODUCT COMPONENT, THIS WAS NOT USED IN A MANUFACTURING PROCESS. THIS IS A MPS B2B PHARMA CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305694 NEEDLE 30X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 8290968 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1