BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM

    MDR report key: 9587176 · Received January 14, 2020

    Report

    Report Number
    9616656-2019-01318
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 27, 2019
    Report Date
    January 17, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403897511
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE PEN NDL 32G 4MM EXPERIENCED DIFFICULT OPERATION OR NOT WORKING/FUNCTIONING, AND WAS UNABLE/DIFFICULT TO DELIVER INSULIN/MEDICATION. PRODUCT DEFECTS WERE NOTICED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320883. BATCH NO: 8010989. VERBATIM: EMAIL RECEIVED REGARDING AN EMAIL LEFT BY CONSUMER EMAIL RECEIVED¿(B)(6) 2019 08:54:19 "HE SAYS THAT THEY GET CLOGGED WHEN HE TRIES TO USE THEM". PER UPDATE ON (B)(6) 2019: CONSUMER STATED, NO INSULIN FLOW WHEN HE INJECTS STATED, HE WAS NEVER TOLD TO PRIME BEFORE INJECTIONS. NOW HE IS PRIMING AND HAS NOT HAD THE PROBLEM SINCE. LOT: 8010989. 4MMX32G BD NANO PEN NEEDLES. DISCARD BOX, SO HE COULD NOT PROVIDE ITEM NUMBER INCIDENT DATE UNKNOWN. 3 PEN NEEDLES AFFECTED. SAMPLES DISCARDED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN: (B)(6) HAS BEEN USED AS A DEFAULT.  A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE PEN NDL 32 G 4 MM EXPERIENCED DIFFICULT OPERATION OR NOT WORKING/FUNCTIONING, AND WAS UNABLE/DIFFICULT TO DELIVER INSULIN/MEDICATION. PRODUCT DEFECTS WERE NOTICED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320883, BATCH NO: 8010989. VERBATIM: EMAIL RECEIVED REGARDING AN EMAIL LEFT BY CONSUMER EMAIL RECEIVED (B)(6) 2019 08:54:19 "HE SAYS THAT THEY GET CLOGGED WHEN HE TRIES TO USE THEM". PER UPDATE ON 12/30/2019: CONSUMER STATED, NO INSULIN FLOW WHEN HE INJECTS STATED, HE WAS NEVER TOLD TO PRIME BEFORE INJECTIONS. NOW HE IS PRIMING AND HAS NOT HAD THE PROBLEM SINCE. LOT: 8010989. 4MMX32G BD NANO PEN NEEDLES. DISCARD BOX, SO HE COULD NOT PROVIDE ITEM NUMBER. INCIDENT DATE UNKNOWN. 3 PEN NEEDLES AFFECTED. SAMPLES DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52636 PEN NDL 32G 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8975 8010989 10885403897511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other