BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II INSULIN SYRINGE

    MDR report key: 17497754 · Received August 10, 2023

    Report

    Report Number
    1920898-2023-00551
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    July 28, 2023
    Report Date
    September 28, 2023
    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES, D.9. RETURNED TO MANUFACTURER ON: 29-AUG-2023. 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 AS SILICONE 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 DEW-LIKE FOREIGN LIQUID WAS FOUND IN THE BD ULTRA-FINE¿ II INSULIN SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THE CUSTOMER REPORTED THAT A DEW-LIKE LIQUID CAME OUT OF THE SYRINGE THAT HAD NOT YET DRAWN INSULIN. THE COMPLAINT PRODUCT WAS RECALLED FROM THE ANIMAL HOSPITAL. FM LIQUID WAS IN ONE PRODUCT, BUT ALL THE PRODUCTS IN THE SAME SHELF CARTON WERE RECALLED DUE TO CONCERNS ABOUT THE PRODUCTS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEW-LIKE FOREIGN LIQUID WAS FOUND IN THE BD ULTRA-FINE¿ II INSULIN SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THE CUSTOMER REPORTED THAT A DEW-LIKE LIQUID CAME OUT OF THE SYRINGE THAT HAD NOT YET DRAWN INSULIN. THE COMPLAINT PRODUCT WAS RECALLED FROM THE ANIMAL HOSPITAL. FM LIQUID WAS IN ONE PRODUCT, BUT ALL THE PRODUCTS IN THE SAME SHELF CARTON WERE RECALLED DUE TO CONCERNS ABOUT THE PRODUCTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381900 BD ULTRA-FINE¿ II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2178033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown