BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 18816445 · Received March 1, 2024

    Report

    Report Number
    9616656-2024-05121
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    January 5, 2024
    Report Date
    May 24, 2024
    Manufacturer
    BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H6, H10 CORRECTION TO H6, DEVICE CODE, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 2ND COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    VOICEMAIL: CONSUMER LEFT VOICEMAIL REPORTING THAT THERE IS A PROBLEM WITH THE NEEDLES. I RETURNED CONSUMER'S CALL AND SHE STATED THAT THERE IS NO INSULIN FLOW DURING PRIMING, STATED THAT SHE PRIMES WITH 1 UNIT. CONSUMER DOES NOT RE-USE. CONSUMER REFUSED REPLACEMENT, STATED THAT SHE GETS NEEDLES FROM MAIL ORDER PHARMACY. I OFFERED TO SEND A BOX TO THE PHARMACY OR DOCTOR'S OFFICE BUT CONSUMER REJECTED THE OFFER AND DISCONNECTED THE CALL. SHE WANTED THE BOX TO BE SENT TO HER HOME AND I ADVISED HER THAT WE WERE NOT PERMITTED TO SEND SHARPS TO HOME ADDRESS. (B)(6). LOT #: 3143587 CATALOG #: 320122 DATE OF EVENT: 01-05-24 SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310008 PEN NDL 32G 4MM 100BX 1200 USA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND 320122 3143587 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown