BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PRO PEN NEEDLE

    MDR report key: 17545240 · Received August 14, 2023

    Report

    Report Number
    9616656-2023-00883
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 31, 2023
    Report Date
    November 22, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    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 FIELD WAS UPDATED DUE TO CORRECTION: IMDRF ANNEX C GRID: FROM C070603 - FRACTURE PROBLEM TO C070601 - DEFORMATION PROBLEM H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST 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 CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT THE NON-PATIENT END OF THE BD MICRO-FINE¿ PRO PEN NEEDLE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT A BENT NEEDLE. THE FEMALE PATIENT IN HER 40S HAS A LONG HISTORY OF INSULIN USE. SHE NOTICED A MIXTURE OF THE BENT NEEDLE. WHEN THE NEEDLE SEAL WAS REMOVED , THE NEEDLE WAS ALREADY BENT. SINCE THE PATIENT CLAIMED THAT THE NEEDLE WAS NOT ATTACHED TO THE PEN, VERIFICATION OF THE TRACES OF ATTACHMENT TO THE PEN IS REQUIRED" VIA BDJ INVESTIGATION TEAM: "3 DEFECT SAMPLES WERE RETURNED. BDJ CONFIRMED 2 NP NEEDLE BENT AND 1 NP NEEDLE BROKEN."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NON-PATIENT END OF THE BD MICRO-FINE¿ PRO PEN NEEDLE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT A BENT NEEDLE. THE FEMALE PATIENT IN HER 40S HAS A LONG HISTORY OF INSULIN USE. SHE NOTICED A MIXTURE OF THE BENT NEEDLE. WHEN THE NEEDLE SEAL WAS REMOVED , THE NEEDLE WAS ALREADY BENT. SINCE THE PATIENT CLAIMED THAT THE NEEDLE WAS NOT ATTACHED TO THE PEN, VERIFICATION OF THE TRACES OF ATTACHMENT TO THE PEN IS REQUIRED". VIA BDJ INVESTIGATION TEAM: "3 DEFECT SAMPLES WERE RETURNED. BDJ CONFIRMED 2 NP NEEDLE BENT AND 1 NP NEEDLE BROKEN.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NON-PATIENT END OF THE BD MICRO-FINE¿ PRO PEN NEEDLE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT A BENT NEEDLE. THE FEMALE PATIENT IN HER 40S HAS A LONG HISTORY OF INSULIN USE. SHE NOTICED A MIXTURE OF THE BENT NEEDLE. WHEN THE NEEDLE SEAL WAS REMOVED , THE NEEDLE WAS ALREADY BENT. SINCE THE PATIENT CLAIMED THAT THE NEEDLE WAS NOT ATTACHED TO THE PEN, VERIFICATION OF THE TRACES OF ATTACHMENT TO THE PEN IS REQUIRED" VIA BDJ INVESTIGATION TEAM: "3 DEFECT SAMPLES WERE RETURNED. BDJ CONFIRMED 2 NP NEEDLE BENT AND 1 NP NEEDLE BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249114 BD MICRO-FINE¿ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2130219

    Patients

    Seq Age Sex Outcome Treatment
    1 Female