BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    MDR report key: 11458208 · Received March 11, 2021

    Report

    Report Number
    9616656-2021-00241
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 11, 2021
    Report Date
    May 12, 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
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-04-30 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A TOTAL OF 23 PEN NEEDLES, ALL 4MM AND 32 GAUGE IN SIZE. 15 WERE RETURNED ONLY WITH GREEN INNER SHIELDS, WHILE 8 WERE RETURNED WITH THEIR TEAR DROP LABELS FEATURING LOT 0112352. THE PEN NEEDLES WERE TESTED FOR LEAKS VIA SIMULATED USE. THE PEN NEEDLES WERE ATTACHED TO A TEST PEN FILLED WITH SALINE. THE PEN WAS PRIMED AND SALINE WAS PUSHED THROUGH THE SYSTEM. THE SALINE EXITED THE PEN NEEDLES WITHOUT ANY ISSUES. AFTER SWITCHING ONE PEN NEEDLE FOR ANOTHER SEVERAL TIMES, IT WAS NOTED THAT SALINE COULD LEAK FROM THE DISTAL TIP OF THE NEEDLE. SALINE WOULD GATHER AT THE TIP AND FORM A BEAD WITHOUT INPUT. IT IS BELIEVED THAT THIS IS THE RESULT OF RESIDUAL PRESSURE IN THE SYSTEM FORCING OUT A MINUTE AMOUNT OF SOLUTION. LEAKING WOULD NOT OCCUR ANYWHERE ELSE IN THE SYSTEM. THE LEAK WOULD STOP AS PRESSURE WAS NORMALIZED IN THE SYSTEM. NO PROBLEMS FOUND DIRECTLY WITH ANY OF THE RETURNED PEN NEEDLES REGARDING LEAKS. 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 SAMPLES RECEIVED, BD WAS UNABLE TO REPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF LEAKAGE. 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 LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT PEN NEEDLE IS LEAKING INSULIN. VERBATIM: FROM PHONE CALL ON 2021-02-12 15:50:11: CONSUMER STATED, PEN NEEDLES ARE LEAKING DURING AND AFTER INJECTION. STATED, SHE'S NEVER HAD THIS ISSUE WITH ORIGINAL NANO PEN NEEDLES. STATED, THERE WAS A SECOND LOT BUT SHE DISCARDED THE BOX. LOT: 0112852 CATALOG: 320550 DATE OF EVENT: UNKNOWN SAMPLES: YES CL EMAIL RECEIVED¿2021-02-11 14:09:02GOOD MORNING,I HAVE BEEN USING THESE NEEDLES FOR A NUMBER OF YEARS. YOU RECENTLY CHANGED THE DESIGN ON THE NEEDLE COVER AND WITH THESE NEW NEEDLES I'VE SEEN A CHANGE IN THEIR ABILITY TO RETAIN THE INSULIN. ONCE I SCREW IN THE NEEDLE TO MY LANTUS PEN, IT BEGINS TO LEAK A LITTLE. AFTER THE INJECTION IT'S THE SAME THING. I GET LEAKAGE WHEN I REMOVE THE NEEDLE FROM MY SKIN AND BEFORE I CAN GET IT TO THE SHARPES CONTAINER. IT'S NOT FUN TO HAVE IT DRIPPING ON ME AND ON MY COUNTERTOP. THIS DID NOT HAPPEN WITH THE OLDER NEEDLES. THE LOT NUMBER ON THESE PENS IS 0112352 WITH AN EXP DATE OF 4/30/2025. MY QUESTION FOR YOU IS THIS: WILL THIS ALWAYS BE TRUE OF THE NEWER STYLE NEEDLES OR WAS THIS SOME TYPE OF TEMPORARY THING? THANKS SO MUCH,"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0112352, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-04-21. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. 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 LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT PEN NEEDLE IS LEAKING INSULIN. VERBATIM: FROM PHONE CALL ON (B)(6) 2021 15:50:11: CONSUMER STATED, PEN NEEDLES ARE LEAKING DURING AND AFTER INJECTION. STATED, SHE'S NEVER HAD THIS ISSUE WITH ORIGINAL NANO PEN NEEDLES. STATED, THERE WAS A SECOND LOT BUT SHE DISCARDED THE BOX. LOT: 0112852, CATALOG: 320550, DATE OF EVENT: UNKNOWN, SAMPLES: YES CL.. EMAIL RECEIVED 2021-02-11 14:09:02GOOD MORNING,I HAVE BEEN USING THESE NEEDLES FOR A NUMBER OF YEARS. YOU RECENTLY CHANGED THE DESIGN ON THE NEEDLE COVER AND WITH THESE NEW NEEDLES I'VE SEEN A CHANGE IN THEIR ABILITY TO RETAIN THE INSULIN. ONCE I SCREW IN THE NEEDLE TO MY LANTUS PEN, IT BEGINS TO LEAK A LITTLE. AFTER THE INJECTION IT'S THE SAME THING. I GET LEAKAGE WHEN I REMOVE THE NEEDLE FROM MY SKIN AND BEFORE I CAN GET IT TO THE SHARPES CONTAINER. IT'S NOT FUN TO HAVE IT DRIPPING ON ME AND ON MY COUNTERTOP. THIS DID NOT HAPPEN WITH THE OLDER NEEDLES. THE LOT NUMBER ON THESE PENS IS 0112352 WITH AN EXP DATE OF 4/30/2025. MY QUESTION FOR YOU IS THIS: WILL THIS ALWAYS BE TRUE OF THE NEWER STYLE NEEDLES OR WAS THIS SOME TYPE OF TEMPORARY THING? THANKS SO MUCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363267 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