BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NDL 32G 4MM HP

    MDR report key: 9814463 · Received March 10, 2020

    Report

    Report Number
    9616656-2020-00207
    Event Type
    Injury
    Date Received
    March 10, 2020
    Date of Event
    February 20, 2020
    Report Date
    February 27, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    50382903630832
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF A TEAR DROP LABEL FOR A 4MM, 32G PEN NEEDLE FROM LOT # 9072616. CUSTOMER STATES THAT WENT TO INJECT, THE NEEDLE WOULD NOT PENETRATE HER SKIN WHEN SHE DEPRESSED THE PLUNGER IF THE PENLET, THE INSULIN WAS SLOW AND DIFFICULT TO DISPENSE: RESULT UNDER DOSAGE. PHOTO WAS EXAMINED AND DID NOT SHOW THE PEN NEEDLES IN QUESTION, ONLY THE TEAR DROP LABEL. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BLUNT NEEDLE WAS FOUND BEFORE USE WITH A PEN NDL 32G 4MM HP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CAPTURES NEEDLE BLUNT, DIFFICULT/UNABLE TO OPERATE (SLOW & DIFFICULT TO DISPENSE), GLUCOSE LEVEL, WITH DATE OF OCCURRENCE (B)(6) 2020. IT WAS REPORTED THAT THE NEEDLE WAS DULL AND THE INSULIN WAS DIFFICULT TO DISPENSE VERBATIM: I DON¿T BELIEVE THE THREE SUSPECT NEEDLES WERE SHARP ENOUGH, THE FIRST TIME IT HAPPENED I DIDN¿T GET THE NEEDLE IN. I DIDN¿T THING ANYTHING OF IT AND DISPOSED OF THE OFFENDING NEEDLE IN THE BIOHAZARD DISPOSAL. AND STARTED AGAIN. IT HAPPENED AGAIN THURSDAY (B)(6) WHEN I WENT TO INJECT AND THE NEEDLE WOULDN¿T PENETRATE MY SKIN¿ WHEN I DEPRESSED THE PLUNGER OF THE PENLET, THE INSULIN WAS SLOW AND DIFFICULT TO DISPENSE. RESULT: UNDER DOSAGE. HOWEVER TWO DAYS LATER, ON SATURDAY (B)(6), I WENT TO INJECT AND THE SAME THING HAPPENED AGAIN. (NOTE: INJECTION SITE IS CONSISTENTLY MOVED AROUND.) THIS TIME PELNET GOT OUT 5U (WITH DIFFICULTY) BUT THE INSULIN ROLLED OUT ONTO MY SKIN. I PUT THIS NEEDLE IN THE BIOHAZARD DISPOSAL AND GOT A NEW NEEDLE AND STARTED AGAIN. THE SECOND ATTEMPT WORKED. RESULT: OVER DOSAGE BUT NOT BY MUCH IF ANY AT ALL. I SAVED THE ¿PEEL OFF¿ LABEL AND TOOK PICTURES OF IT BUT UNFORTUNATELY DID NOT SAVE THE DEFECTIVE NEEDLE AS NOT TO GET IT MIXED UP WITH THE NEW ONE. I COUNTED THE REMAINING NEEDLED AND HAVE 99 NEEDLES LEFT FROM TWO BOXES EACH OF 100. I BUY TWO BOXES OF 100 AT A TIME SO I ASSUME THE 200 WERE ALL THE SAME LOT NUMBER. I NO LONGER HAVE THE BOXES THEY CAME IN AS I THROW THEM OUT ONCE I OPEN THEM. I DO HAVE THE RECEIPT AS I SUBMIT IT TO OUT BENEFITS PROVIDER FOR REIMBURSEMENT. PER UPDATE BY US COM ON 06/03/2020 FROM PHONE CALL ON 2020-03-06 17:07:06: REACHED OUT TO CONSUMER: DISCARDED SAMPLES STATED, PRIMES BEFORE INJECTION STATED, NUMBER WERE NOT AFFECTED." 1 OF 3 COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278203 PEN NDL 32G 4MM HP PEN NEEDLE FMI BECTON DICKINSON AND CO. 363083 9072616 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other