BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 18213521 · Received November 27, 2023

    Report

    Report Number
    1920898-2023-00789
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    October 1, 2023
    Report Date
    February 1, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2052388. D4. MEDICAL DEVICE EXPIRATION DATE: 31MAR2027. H4. DEVICE MANUFACTURE DATE: 21FEB2022. D4. MEDICAL DEVICE LOT #: 2255780. D4. MEDICAL DEVICE EXPIRATION DATE: 30SEP2027. H4. DEVICE MANUFACTURE DATE: 12SEP2022. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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 2052388 AND THE 2ND COMPLAINT FOR THE REPORTED LOT NUMBER 2255780. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 OF THE BD ULTRA-FINE¿ INSULIN SYRINGE HAD SCALE MARKING ISSUES. THE FOLLOWING WAS TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A COMPLAINT ABOUT SCRATCHES ON THE SCALE MARKING AREA. CUSTOMER REPORTED THAT THREE PRODUCT HAD SCRATCHES ON THE FIVE PLACES OF SCALE MARKING AREA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 OF THE BD ULTRA-FINE¿ INSULIN SYRINGE HAD SCALE MARKING ISSUES. THE FOLLOWING WAS TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A COMPLAINT ABOUT SCRATCHES ON THE SCALE MARKING AREA. CUSTOMER REPORTED THAT THREE PRODUCT HAD SCRATCHES ON THE FIVE PLACES OF SCALE MARKING AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764760 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown