BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 CA

    MDR report key: 10039652 · Received May 8, 2020

    Report

    Report Number
    2243072-2020-00739
    Event Type
    Malfunction
    Date Received
    May 8, 2020
    Date of Event
    May 1, 2020
    Report Date
    May 4, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. UNABLE TO PERFORM DHR CHECK DUE TO AN UNKNOWN LOT NUMBER FOR NDLE PT BLUNT, DIF. /UNABLE TO OP. OUTER COVER, DIF/UN. TO OPER. INNER SHIELD. DIF. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEN NDL 32G 4MM HP 100 BOX 1200 CA WAS DIFFICULT TO PRESS INTO THE INJECTION SITE, AND THE OUTER COVER AND INNER SHIELD WERE HARD TO GRASP DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NEEDLES ARE HARD TO PRESS INTO HER SITE. WAS USING 320144 PRIOR TO PRO BUT WITH EASE. ITEM # 320555 LOT # UNKNOWN FIRST BOX USED FINDING NEEDLES HARD TO PRESS INTO THE SITE CONSUMER REPORTED THE OUTER COVER HARD TO GRASP. CONSUMER REPORTED THE INNER SHIELDS HARD TO GRASP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504615 PEN NDL 32G 4MM HP 100 BOX 1200 CA PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other