BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 12750838 · Received November 4, 2021

    Report

    Report Number
    1920898-2021-01147
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Date of Event
    October 6, 2021
    Report Date
    December 13, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED IMAGES OF A SYRINGE FROM A POLYBAG LABELED FOR 0.5ML, 31 GAUGE, 6MM SYRINGES. THE THUMB PRESS OF THE PLUNGER ROD IS MISSING ENTIRELY. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0153008. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE IMAGES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF A BROKEN PLUNGER ROD. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE, THE DEVICE EXPERIENCED A DAMAGED PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: A PROFESSIONAL CONTACTED US INFORMING US THAT A CLIENT PURCHASED A SYRINGE PACKAGE AND THAT SHE FOUND A SYRINGE IN THE PACKAGE WAS BROKEN IN THE PART OF THE PLUNGER, MAKING ITS USE IMPOSSIBLE. THEY EXCHANGED THE PRODUCT FOR THE PATIENT AND REQUESTED A REPLACEMENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE, THE DEVICE EXPERIENCED A DAMAGED PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: A PROFESSIONAL CONTACTED US INFORMING US THAT A CLIENT PURCHASED A SYRINGE PACKAGE AND THAT SHE FOUND A SYRINGE IN THE PACKAGE WAS BROKEN IN THE PART OF THE PLUNGER, MAKING ITS USE IMPOSSIBLE. THEY EXCHANGED THE PRODUCT FOR THE PATIENT AND REQUESTED A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652655 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 0153008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown