BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 15488806 · Received September 26, 2022

    Report

    Report Number
    9610847-2022-00367
    Event Type
    Malfunction
    Date Received
    September 26, 2022
    Date of Event
    August 31, 2022
    Report Date
    October 3, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903097036
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 1 PHOTO AND 12 SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LEAKAGE PAST STOPPER WAS CONFIRMED UPON INSPECTION OF THE PHOTO. HOWEVER, SINCE THE SAMPLES WERE RETURNED WITH AN UNKNOWN MEDICATION THE SAMPLES COULD NOT BE THOROUGHLY ANALYZED. ONLY A LIMITED EXAMINATION COULD BE PERFORMED. BD WAS NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE FAILURE SHOWN IN THE SAMPLE PHOTO WITH THE LIMITED EXAMINATION. UNUSED PHYSICAL SAMPLES FROM THE COMPLAINT LOTS ARE REQUIRED FOR A MORE IN-DEPTH EVALUATION. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH WAS IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: . MEDICAL DEVICE LOT #: 2153045, . MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027, DEVICE MANUFACTURE DATE: 20-JUN-2022. MEDICAL DEVICE LOT #: 2090477, MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027,. DEVICE MANUFACTURE DATE: 14-APR-2022. 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 ONE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY SYRINGE EACH FROM LOTS 2153045 AND 2090477 LEAKED PAST THE PLUNGER STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 'I JUST WANTED TO REPORT THAT MY STAFF FOUND 5 ML SYRINGES THAT WERE LEAKING PAST THE RUBBER STOPPER".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY SYRINGE EACH FROM LOTS 2153045 AND 2090477 LEAKED PAST THE PLUNGER STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 'I JUST WANTED TO REPORT THAT MY STAFF FOUND 5 ML SYRINGES THAT WERE LEAKING PAST THE RUBBER STOPPER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077200 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H10 00382903097036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown