BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 17485197 · Received August 8, 2023

    Report

    Report Number
    1920898-2023-00540
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 24, 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
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE RECEIVED; THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO PROVIDED. 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 CONFIRM THE CUSTOMER-INDICATED FAILURE. 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. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    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 3 BD ULTRA-FINE¿ INSULIN SYRINGES HAD NO LOT INFORMATION LISTED ON THEIR LABELING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LOT.2213126 SPOTTED BOX = 16 SP AND LOT.2255396 NO LOT = 3 SP."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD ULTRA-FINE¿ INSULIN SYRINGES HAD NO LOT INFORMATION LISTED ON THEIR LABELING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LOT.2213126 SPOTTED BOX : 16 SP AND LOT.2255396 NO LOT: 3 SP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688348 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2255396

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown