BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGES 1ML

    MDR report key: 17187407 · Received June 22, 2023

    Report

    Report Number
    1920898-2023-00382
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    May 30, 2023
    Report Date
    August 17, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 23-JUN-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 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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 THE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGES 1ML STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS PER ACCOUNT, ONE OF OUR NSP SATELLITE SITES REACHED OUT TO US ABOUT THE BD ULTRA SHORT TIP (30G) NEEDLE/SYRINGE COMBOS, LOT# 1103828, EXP. 06-26 PACKAGING COMING APART. THESE SYRINGES ARE SEPARATELY PACKAGES IN BUNDLES OF 5 AND THE 5TH ONE HAS FALLEN OUT OF THE PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGES 1ML STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS PER ACCOUNT, ONE OF OUR NSP SATELLITE SITES REACHED OUT TO US ABOUT THE BD ULTRA SHORT TIP (30G) NEEDLE/SYRINGE COMBOS, LOT# 1103828, EXP. 06-26 PACKAGING COMING APART. THESE SYRINGES ARE SEPARATELY PACKAGES IN BUNDLES OF 5 AND THE 5TH ONE HAS FALLEN OUT OF THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71658 BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGES 1ML PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1103828

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown