BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 16808992 · Received April 25, 2023

    Report

    Report Number
    1920898-2023-00256
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    April 3, 2023
    Report Date
    April 27, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2010737. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2066123. D.4. MEDICAL DEVICE EXPIRATION DATE: (B)(6) 2027. H.4. DEVICE MANUFACTURE DATE: (B)(6) 2022. D.4. MEDICAL DEVICE LOT #: 2010737. D.4. MEDICAL DEVICE EXPIRATION DATE: (B)(6) 2027. H.4. DEVICE MANUFACTURE DATE: (B)(6) 2022. 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 SOME OF THE PACKAGES OF THE 6MM BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE CONTAINED 8MM NEEDLES. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF SYRINGES IN LOTS 2066123 AND 2010737. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "CAREGIVER CONTACTS TO INFORM THAT SINCE JANUARY SOME PACKAGES OF BD ULTRA-FINE 6MM SYRINGES IN THE CAPACITY OF 30UI ARE WITH SOME 8MM NEEDLES (AROUND 3 TO 4 SYRINGES PER PACKAGE). SHE USES IT TO APPLY SOMATROPIN TO HER DAUGHTER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME OF THE PACKAGES OF THE 6MM BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE CONTAINED 8MM NEEDLES. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF SYRINGES IN LOTS 2066123 AND 2010737. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "CAREGIVER CONTACTS TO INFORM THAT SINCE (B)(6) SOME PACKAGES OF BD ULTRA-FINE 6MM SYRINGES IN THE CAPACITY OF 30UI ARE WITH SOME 8MM NEEDLES (AROUND 3 TO 4 SYRINGES PER PACKAGE). SHE USES IT TO APPLY SOMATROPIN TO HER DAUGHTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092569 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown