BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE INSULIN SYRINGE

    MDR report key: 8330991 · Received February 12, 2019

    Report

    Report Number
    2243072-2019-00215
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Date of Event
    January 25, 2019
    Report Date
    November 22, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WITH THE USE OF THE BD MICRO-FINE¿ SYRINGE THERE WAS AN ISSUE WITH THE STOPPER APPEARING TO BE DRY ROTTED AND AIR BUBBLES WHEN DRAWING INSULIN. BRAND NAME: BD MICRO-FINE¿ SYRINGE. MEDICAL DEVICE CATALOG#: 8465. MEDICAL DEVICE LOT #: 1A914 E. MEDICAL DEVICE EXPIRATION DATE: 01/31/1996. UNIQUE IDENTIFIER (UDI) #: N/A. PMA / 510(K)#: N/A. DEVICE MANUFACTURE DATE: 01/01/1991. INVESTIGATION: THE CUSTOMER RETURNED EXPIRED SYRINGE PRODUCT FROM A PRE-SAP LOT NUMBER (1A914 E) AND CAT #8465, THEREFORE UNABLE TO PERFORM EVALUATION ON OLD PRODUCT INFORMATION. CUSTOMER RETURNED SEVEN (7) 28G X 12.7MM, 0.5ML BD INSULIN SYRINGES IN AN OPENED POLYBAG FROM LOT 1A914 E. CONSUMER CALLED IN INITIALLY FOR ASSISTANCE ON EXPIRATION DATE OF SYRINGES THAT WERE GIVEN TO HER. STATED THE STOPPER APPEARED "DRY ROTTED" AND WHEN SHE DRAWS INSULIN, THERE ARE AIR BUBBLES. THE RETURNED SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT THE PLASTIC COMPONENTS (ESPECIALLY THE PLUNGER) APPEARED ORANGE DUE TO THE EXTENSIVE AGING (OXIDATION). AS PER MANUFACTURING: THE SYRINGE SAMPLES FROM LOT 1A914 E WERE MANUFACTURED IN 1991 (28 YEARS OLD). THE SHELF LIFE FOR BD INSULIN SYRINGE PRODUCT IS 5 YEARS, THEREFORE, THE PRODUCT RECEIVED FOR THIS COMPLAINT IS EXPIRED, AND THE ALLEGED ISSUES CANNOT BE CONFIRMED. AS PER MANUFACTURING: DHRS ARE LEGALLY KEPT FOR 7 YEARS AFTER THE BATCH CREATION DATE. LOT NUMBER 1A914 E WAS MANUFACTURED IN 1991 (28 YEARS SINCE BATCH CREATION DATE), THUS THE DHR FOR THIS LOT NUMBER IS NO LONGER AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. UNABLE TO PERFORM DHR DUE TO UNKNOWN LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD MICRO-FINE¿ SYRINGE THERE WAS AN ISSUE WITH THE STOPPER APPEARING TO BE DRY ROTTED AND AIR BUBBLES WHEN DRAWING INSULIN.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE UNSPECIFIED BD MICRO-FINE¿ SYRINGE THERE WAS AN ISSUE WITH THE STOPPER APPEARING TO BE DRY ROTTED AND AIR BUBBLES WHEN DRAWING INSULIN.

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE UNSPECIFIED BD MICRO-FINE¿ SYRINGE THERE WAS AN ISSUE WITH THE STOPPER APPEARING TO BE DRY ROTTED AND AIR BUBBLES WHEN DRAWING INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123576 BD MICRO-FINE INSULIN SYRINGE INSULIN SYRINGE FMF BECTON DICKINSON 1A914 E

    Patients

    Seq Age Sex Outcome Treatment
    1 Other