BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ PRO PEN NEEDLE

    MDR report key: 15929309 · Received December 6, 2022

    Report

    Report Number
    9616656-2022-01323
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 11, 2022
    Report Date
    January 31, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205592
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO RECEIVING ADDITIONAL INFORMATION FROM THE CUSTOMER: D.4. MEDICAL DEVICE LOT #: 2060475. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027. H.4. DEVICE MANUFACTURE DATE: 01-MAR-2022. H.6. 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 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 NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER E-MAIL: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿+ PRO PEN NEEDLE FAILED TO DELIVER MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT FROM THE PHARMACIST. STATING THAT THE DRUG SOLUTION DID NOT COME OUT, ONE PATIENT BROUGHT THE AFFECTED PEN NEEDLE TO THE PHARMACY. THE PHARMACIST ATTEMPTED AND CONFIRMED THAT THE DRUG SOLUTION DID NOT COME OUT. WHEN ANOTHER PEN NEEDLE WAS ATTACHED TO THE PEN, THE DRUG SOLUTION COME OUT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿+ PRO PEN NEEDLE FAILED TO DELIVER MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT FROM THE PHARMACIST. STATING THAT THE DRUG SOLUTION DID NOT COME OUT, ONE PATIENT BROUGHT THE AFFECTED PEN NEEDLE TO THE PHARMACY. THE PHARMACIST ATTEMPTED AND CONFIRMED THAT THE DRUG SOLUTION DID NOT COME OUT. WHEN ANOTHER PEN NEEDLE WAS ATTACHED TO THE PEN, THE DRUG SOLUTION COME OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044070 BD MICRO-FINE¿+ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2060475 00382903205592

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown