BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II INSULIN SYRINGE

    MDR report key: 18083379 · Received November 7, 2023

    Report

    Report Number
    1920898-2023-00752
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    October 23, 2023
    Report Date
    February 1, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 17NOV2023. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD ULTRA-FINE¿ II INSULIN SYRINGE, THE REPORTED STATED 3 OR 4 NEEDLES BROKE OFF WHEN TRYING TO INJECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EMAIL: ISSUE: AT LEAST 7 SYRINGES NEEDLES WERE DULL/BLUNT UNABLE TO PENETRATE SKIN. 3 OR 4 NEEDLES BROKE OFF WHEN TRYING TO INJECT. NO PT HARM HAD SOME BRUISING. HAS SAMPLES AVAILABLE. LOT #: 3072879 CATALOG #: UNKNOWN, DATE OF EVENT: UNKNOWN, SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD ULTRA-FINE¿ II INSULIN SYRINGE, THE REPORTED STATED 3 OR 4 NEEDLES BROKE OFF WHEN TRYING TO INJECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EMAIL: ISSUE: AT LEAST 7 SYRINGES NEEDLES WERE DULL/BLUNT UNABLE TO PENETRATE SKIN. 3 OR 4. NEEDLES BROKE OFF WHEN TRYING TO INJECT. NO PT HARM HAD SOME BRUISING. HAS SAMPLES AVAILABLE. LOT #: 3072879. CATALOG #: UNKNOWN. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350240 BD ULTRA-FINE¿ II INSULIN SYRINGE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 3072879

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown