BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    MDR report key: 11829437 · Received May 14, 2021

    Report

    Report Number
    9616656-2021-00532
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 16, 2021
    Report Date
    May 18, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM HP 100 BOX 1200 US HAD EXCESSIVE CANNULA LENGTH, DAMAGE, AND WERE DIFFICULT TO PRIME (5). THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: 'IT WAS REPORTED THAT PEN NEEDLES ARE FAULTY, BENT, AND LONGER THAN 4MM. VERBATIM: FROM PHONE CALL ON (B)(6) 2021 17:36:25: PARENT OF 9 YEAR OLD STATED, NO INSULIN FLOWED WHEN PRIMING, (DIALING UP 2 UNITS) LOT: 0231157. CATALOG: 320550. DATE OF EVENT: (B)(6) 2021, (5 PEN NEEDLES AFFECTED). SAMPLES: YES. STATED, SHE'S FOUND THE PATIENT END BENT PRIOR TO INJECTION STATED, WHEN PEN NEEDLE IS ATTACHED, IT'S ON AT A "SLANT" EVEN THOUGH SHE'S PUTTING IT STRAIGHT ON. STATED, NO INSULIN FLOW WHEN PRIMING AND SOMETIMES TAKING INJECTION. STATED, A COUPLE OF BOXES WERE AFFECTED BUT ONE LOT IS UNKNOWN. CL BD NANO PEN NEEDLES, 2ND GEN, 4MM, 100 PACK. PRODUCT NUMBER: 320550. LOT #: 0231157. REASON FOR CALL/EMAIL: LAST 2 BOXES OF PEN NEEDLES WERE FAULTY, BENT AND LONGER THAN 4MM. AS A RESULT, AN EXCESSIVE AMOUNT HAD TO BE THROWN AWAY. PLEASE LET ME KNOW YOU HAVE RECEIVED MY RESPONSE. THANKS IN ADVANCE. EMAIL RECEIVED (B)(6) 2021 18:07:19 GOOD EVENING. WE ARE WRITING WITH CONCERN. WE HAVE EXPERIENCED AN EXCESSIVE AMOUNT OF FAULTY PEN NEEDLES IN THE LAST TWO BOXES WE RECEIVED. THERE HAVE BEEN BENT NEEDLES AND EXTRA LONG NEEDLES-STICKING OUT OF THE CONTAINER IT SITS IN. WHILE WE ARE GRATEFUL WE NOTICED THESE DEFAULTS, WE ARE UNSURE IF WE ADMINISTERED A SHOT WITH A FAULTY NEEDLE. WE REACHED OUT TO OUR PHARMACIST ABOUT PEN NEEDLE REPLACEMENTS BUT THEY SAID WE HAD TO REACH OUT TO THE COMPANY. NOT ONLY DO WE FIRST AND FOREMOST WANT TO SPREAD AWARENESS ABOUT THIS BUT WE HAD TO THROW OUT MANY NEEDLES AS A RESULT. PLEASE INFORM US OF HOW WE CAN GET REPLACEMENTS? THANKS YOU IN ADVANCE FOR YOUR PROMPT RESPONSE AND ASSISTANCE IN THIS MATTER."

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0231157. MEDICAL DEVICE EXPIRATION DATE: 2025-08-31. DEVICE MANUFACTURE DATE: 2020-08-18. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM HP 100 BOX 1200 US HAD EXCESSIVE CANNULA LENGTH, DAMAGE, AND WERE DIFFICULT TO PRIME (5). THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: 'IT WAS REPORTED THAT PEN NEEDLES ARE FAULTY, BENT, AND LONGER THAN 4MM. VERBATIM: FROM PHONE CALL ON (B)(6) 2021 17:36:25: PARENT OF (B)(6) STATED, NO INSULIN FLOWED WHEN PRIMING, (DIALING UP 2 UNITS) LOT: 0231157. CATALOG: 320550. DATE OF EVENT: (B)(6) 2021, (5 PEN NEEDLES AFFECTED). SAMPLES: YES. STATED, SHE'S FOUND THE PATIENT END BENT PRIOR TO INJECTION STATED, WHEN PEN NEEDLE IS ATTACHED, IT'S ON AT A "SLANT" EVEN THOUGH SHE'S PUTTING IT STRAIGHT ON. STATED, NO INSULIN FLOW WHEN PRIMING AND SOMETIMES TAKING INJECTION. STATED, A COUPLE OF BOXES WERE AFFECTED BUT ONE LOT IS UNKNOWN. CL. BD NANO PEN NEEDLES, 2ND GEN, 4MM, 100 PACK. PRODUCT NUMBER: 320550. LOT #: 0231157. REASON FOR CALL/EMAIL: LAST 2 BOXES OF PEN NEEDLES WERE FAULTY, BENT AND LONGER THAN 4MM. AS A RESULT, AN EXCESSIVE AMOUNT HAD TO BE THROWN AWAY. PLEASE LET ME KNOW YOU HAVE RECEIVED MY RESPONSE. THANKS IN ADVANCE. EMAIL RECEIVED (B)(6) 2021 18:07:19 GOOD EVENING. WE ARE WRITING WITH CONCERN. WE HAVE EXPERIENCED AN EXCESSIVE AMOUNT OF FAULTY PEN NEEDLES IN THE LAST TWO BOXES WE RECEIVED. THERE HAVE BEEN BENT NEEDLES AND EXTRA LONG NEEDLES-STICKING OUT OF THE CONTAINER IT SITS IN. WHILE WE ARE GRATEFUL WE NOTICED THESE DEFAULTS, WE ARE UNSURE IF WE ADMINISTERED A SHOT WITH A FAULTY NEEDLE. WE REACHED OUT TO OUR PHARMACIST ABOUT PEN NEEDLE REPLACEMENTS BUT THEY SAID WE HAD TO REACH OUT TO THE COMPANY. NOT ONLY DO WE FIRST AND FOREMOST WANT TO SPREAD AWARENESS ABOUT THIS BUT WE HAD TO THROW OUT MANY NEEDLES AS A RESULT. PLEASE INFORM US OF HOW WE CAN GET REPLACEMENTS? THANKS YOU IN ADVANCE FOR YOUR PROMPT RESPONSE AND ASSISTANCE IN THIS MATTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721436 PEN NDL 32G 4MM HP 100 BOX 1200 US HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 SEE H.10. 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR