BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 16959335 · Received May 18, 2023

    Report

    Report Number
    1920898-2023-00304
    Event Type
    Malfunction
    Date Received
    May 18, 2023
    Date of Event
    April 28, 2023
    Report Date
    June 2, 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

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

    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# 0083432. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 PACKAGES OF BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE HAD DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "PATIENT CONTACTED INFORMING THAT HE RECEIVED A BOX WITH SEVERAL PACKAGES OF SYRINGES FROM BD (COMPLAINT REPLACEMENT) HE INFORMED THAT IN A PACKAGE OF 5 SYRINGES, THEY WERE HARD WITH DIFFICULTY PULLING THE PLUNGER AND ANOTHER PACKAGE OF 3 SYRINGES HAD THE SAME PROBLEM, ALL FROM THE SAME BATCH... IN WHAT SITUATION WAS THE DEVIATION IDENTIFIED? DURING HANDLING. WAS THERE ANY DAMAGE TO HEALTH? NO"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 PACKAGES OF BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE HAD DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "PATIENT CONTACTED INFORMING THAT HE RECEIVED A BOX WITH SEVERAL PACKAGES OF SYRINGES FROM BD (COMPLAINT REPLACEMENT) HE INFORMED THAT IN A PACKAGE OF 5 SYRINGES, THEY WERE HARD WITH DIFFICULTY PULLING THE PLUNGER AND ANOTHER PACKAGE OF 3 SYRINGES HAD THE SAME PROBLEM, ALL FROM THE SAME BATCH... IN WHAT SITUATION WAS THE DEVIATION IDENTIFIED? DURING HANDLING. WAS THERE ANY DAMAGE TO HEALTH? NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874078 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0083432

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female