BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROFINE¿+ INSULIN SYRINGES

    MDR report key: 16318536 · Received February 8, 2023

    Report

    Report Number
    1920898-2023-00042
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 14, 2023
    Report Date
    May 13, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00382904826017
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES., D9: RETURNED TO MANUFACTURER ON: 09-FEB-2023. H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST RELATED 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 HENCE THE ROOT CAUSE IS UNDETERMINED. 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 SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED WHILE USING BD MICROFINE¿+ INSULIN SYRINGES THE SCALE MARKINGS WERE MISALIGNED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: THE SYRINGES WITH THE ABOVE-MENTIONED BATCH PZN 4144150 HAVE INACCURATE SCALING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROFINE¿+ INSULIN SYRINGES THE SCALE MARKINGS WERE MISALIGNED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: THE SYRINGES WITH THE ABOVE-MENTIONED BATCH PZN 4144150 HAVE INACCURATE SCALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250518 BD MICROFINE¿+ INSULIN SYRINGES HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 2024608 00382904826017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown