BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 31G 5MM 5B XTW 105BX DE

    MDR report key: 11466962 · Received March 11, 2021

    Report

    Report Number
    9616656-2021-00248
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 14, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO OF A 31G X 5MM PEN NEEDLE CARTON ALONG WITH A PHOTO OF AN OPEN PEN NEEDLE COVER WERE RETURNED FROM LOT. NO. 0091889, CAT. NO. 320522. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT AND RED MARKS ON THE COVER WERE OBSERVED. NO PHYSICAL SAMPLE WAS RETURNED FOR INVESTIGATION. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE PHOTO PROVIDED AND THE FACT NO PHYSICAL SAMPLE WAS RETURNED FOR INVESTIGATION THIS CANNOT BE CONFIRMED TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PN 31G 5MM 5B XTW 105BX DE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ADDITIONAL INFO: 1. INJECTION DONE BY PATIENT HIMSELF. 2. INJECTION IN LEG. PATIENT SUGGESTS THAT THERE WAS CONTACT WITH BLOOD. 3. CONTAMINATION REALIZED AFTER USES = CONFIRMED. IMPURITIES / RED PARTICLES IN THE CAP OF THE TIP FOR INSULIN PEN, TIP WAS USED, CONTAMINATION WAS ONLY DISCOVERED AFTER USE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PN 31G 5MM 5B XTW 105BX DE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ADDITIONAL INFO: INJECTION DONE BY PATIENT HIMSELF. INJECTION IN LEG. PATIENT SUGGESTS THAT THERE WAS CONTACT WITH BLOOD. CONTAMINATION REALIZED AFTER USES: CONFIRMED. IMPURITIES / RED PARTICLES IN THE CAP OF THE TIP FOR INSULIN PEN, TIP WAS USED, CONTAMINATION WAS ONLY DISCOVERED AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357735 PN 31G 5MM 5B XTW 105BX DE PEN NEEDLE FMI BECTON DICKINSON AND CO. 0091889

    Patients

    Seq Age Sex Outcome Treatment
    1