BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NDL 31GA 5MM 100BX 1200 USA

    MDR report key: 11646443 · Received April 10, 2021

    Report

    Report Number
    9616656-2021-00375
    Event Type
    Injury
    Date Received
    April 10, 2021
    Date of Event
    March 14, 2021
    Report Date
    May 6, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201198
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 31GA 5MM 100BX 1200 USA BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PATIENT END BROKE OFF INTO HIS STOMACH AND THE INSULIN THEN RAN DOWN FROM THE INJECTION SITE. THE PATIENT WENT TO THE ER FOR AN X-RAY BUT THE NEEDLE WAS NOT FOUND AND THE CONSUMER IS IN PAIN. VERBATIM: CONSUMER STATED, WHEN TAKING INJECTION, HE FELT INSULIN RUNNING DOWN HIS INJECTION SITE BECAUSE THE PATIENT END BROKE OFF IN HIS STOMACH. STATED, HE WENT TO THE EMERGENCY ROOM. STATED, AN XRAY WAS DONE BUT NO NEEDLE WAS FOUND. STATED, HE IS IN PAIN. STATED, HE REFUSED MEDICATION FOR PAIN BECAUSE HE IS A RECOVERING ADDICT. STATED, HE WAS REFERRED TO A SURGEON AND HIS APPOINTMENT IS TODAY. STATED, HE'S GETTING A LAWYER AND BD SHOULD BE HEARING FROM HIS ATTORNEY".

    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 A PEN NDL 31GA 5MM 100BX 1200 USA BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PATIENT END BROKE OFF INTO HIS STOMACH AND THE INSULIN THEN RAN DOWN FROM THE INJECTION SITE. THE PATIENT WENT TO THE ER FOR AN X-RAY BUT THE NEEDLE WAS NOT FOUND AND THE CONSUMER IS IN PAIN. VERBATIM: CONSUMER STATED, WHEN TAKING INJECTION, HE FELT INSULIN RUNNING DOWN HIS INJECTION SITE BECAUSE THE PATIENT END BROKE OFF IN HIS STOMACH. STATED, HE WENT TO THE EMERGENCY ROOM. STATED, AN XRAY WAS DONE BUT NO NEEDLE WAS FOUND. STATED, HE IS IN PAIN. STATED, HE REFUSED MEDICATION FOR PAIN BECAUSE HE IS A RECOVERING ADDICT. STATED, HE WAS REFERRED TO A SURGEON AND HIS APPOINTMENT IS TODAY. STATED, HE'S GETTING A LAWYER AND BD SHOULD BE HEARING FROM HIS ATTORNEY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543944 PEN NDL 31GA 5MM 100BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320119 0070047 00382903201198

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention