BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 25X1 RB

    MDR report key: 11121860 · Received January 6, 2021

    Report

    Report Number
    1213809-2020-00949
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    November 12, 2020
    Report Date
    January 14, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE PHOTO OF A LOOSE SAFETYGLIDE NEEDLE ASSEMBLY WAS RECEIVED AND EVALUATED. IN THE PHOTO, THE SHIELD WAS REMOVED, AND THE CANNULA WAS EXPOSED. IT WAS OBSERVED THERE WAS A CLUSTER WHITE FOREIGN MATTER FIBERS PRESENT ON AND NEAR THE TIP OF THE CANNULA. THE FOREIGN MATTER APPEARED TO BE PLASTIC AND WAS LARGE ENOUGH IN SIZE TO BE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE NEEDLE SUPPLIER¿S MANUFACTURING PROCESS. THE PHOTO WAS FORWARDED TO THE NEEDLE SUPPLIER FOR FURTHER EVALUATION AND INVESTIGATION. HOWEVER, WITH NO PHYSICAL SAMPLE ANALYSIS CONFIRMATION OF THE TYPE OF FOREIGN MATTER, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE SFTYGLD 25X1 RB HAD FOREIGN MATTER ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305916 BATCH NO.: 7082799. IT WAS REPORTED THAT THERE WAS A COTTON-LIKE SUBSTANCE FOUND ON THE NEEDLE PRIOR TO INJECTION. PER EMAIL: INCIDENT DETAILS: I WENT TO GIVE A BABE AN INJECTION AND ONCE I UNCAPPED THE NEEDLE, I NOTICED THAT THERE WAS SOMETHING ON THE END OF IT (LOOKED ALMOST LIKE COTTON BALL FUZZ) BUT I HADN'T TAKEN THE LID OFF BEFORE SO I KNOW IT CAME LIKE THIS. I NOTICED IT WAS NOT RIGHT BEFORE I VACCINATED, SO I RECAPPED THE NEEDLE AND KEPT IT TO REPORT. I CHOSE A NEW NEEDLE FOR INJECTION AND THE NEXT ONE WAS FINE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE SFTYGLD 25X1 RB HAD FOREIGN MATTER ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305916, BATCH NO.: 7082799. IT WAS REPORTED THAT THERE WAS A COTTON-LIKE SUBSTANCE FOUND ON THE NEEDLE PRIOR TO INJECTION. PER EMAIL: INCIDENT DETAILS: I WENT TO GIVE A (B)(6) AN INJECTION AND ONCE I UNCAPPED THE NEEDLE, I NOTICED THAT THERE WAS SOMETHING ON THE END OF IT (LOOKED ALMOST LIKE COTTON BALL FUZZ) BUT I HADN'T TAKEN THE LID OFF BEFORE SO I KNOW IT CAME LIKE THIS. I NOTICED IT WAS NOT RIGHT BEFORE I VACCINATED, SO I RECAPPED THE NEEDLE AND KEPT IT TO REPORT. I CHOSE A NEW NEEDLE FOR INJECTION AND THE NEXT ONE WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21398 NEEDLE SFTYGLD 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305916 7082799 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1