BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 0.3 ML INSULIN SYRINGE WITH ULTRA-FINE NEEDLE

    MDR report key: 12546055 · Received September 29, 2021

    Report

    Report Number
    1920898-2021-01008
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    August 24, 2021
    Report Date
    September 29, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED PHOTOS OF A 3/10CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 0020542. CUSTOMER STATES THAT WHEN REMOVING THE ORANGE CAP TO EXTRACT THE INSULIN, IT BREAKS AND THE NEEDLE REMAINS ATTACHED TO THE CAP AND CANNOT BE USED. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FORM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0020542. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED BD 0.3 ML INSULIN SYRINGE WITH ULTRA-FINE¿ NEEDLE HAD A SEPARATION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "I WRITE BECAUSE MY MOTHER GETS A SYRINGE FOR THE SECOND TIME THAT WHEN REMOVING THE ORANGE CAP TO EXTRACT THE INSULIN, IT BREAKS AND THE NEEDLE REMAINS ATTACHED TO THE CAP AND CANNOT BE USED.".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0020542. MEDICAL DEVICE EXPIRATION DATE: 01/31/2025. UDI#: (B)(4). DEVICE MANUFACTURE DATE: 01/20/2020. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. UDI#: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 FOR THE LOT PROVIDED WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED FOR THE SECOND DEVICE AS NO MATERIAL NUMBER OR LOT NUMBER WAS RECEIVED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BD 0.3 ML INSULIN SYRINGE WITH ULTRA-FINE¿ NEEDLE HAD A SEPARATION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "I WRITE BECAUSE MY MOTHER GETS A SYRINGE FOR THE SECOND TIME THAT WHEN REMOVING THE ORANGE CAP TO EXTRACT THE INSULIN, IT BREAKS AND THE NEEDLE REMAINS ATTACHED TO THE CAP AND CANNOT BE USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447530 BD 0.3 ML INSULIN SYRINGE WITH ULTRA-FINE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1