BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 20490227 · Received October 20, 2024

    Report

    Report Number
    1213809-2024-00737
    Event Type
    Malfunction
    Date Received
    October 20, 2024
    Date of Event
    September 27, 2024
    Report Date
    December 5, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095750
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP MDR FOR DEVICE EVALUATION. ONE SAMPLE AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE SAMPLE WAS ASSEMBLED TO A SYRINGE WITH SALINE SOLUTION. IT EXPELLED SOLUTION THROUGH THE NEEDLE TIP AND THROUGH THE NEEDLE HUB. THE NEEDLE HUB HAS A SHORT SHOT LOCATED ABOUT 1/4" FROM THE BOTTOM OF THE NEEDLE HUB. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4221164. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MATERIAL # 309575; BATCH # 4221164. IT WAS REPORTED THAT THE BD LUER-LOK NEEDLE HUB HAD A HOLD /CRACK / WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. MY STAFF AT OUR CLEANROOM INFORMED ME THAT THEY WERE HAVING ISSUES WITH A FEW OF THE BD PLASTIPAK 3 ML SYRINGES. THEY SAID THAT LOOKS LIKE THERE¿S A HOLE IN THE HUB AND THAT WHEN THEY WERE RETRIEVING DRUG THE DRUG WAS COMING OUT FROM THE HOLE IN THE HUB. LOT # 4221164. I DON¿T THINK IT WILL BE POSSIBLE TO SEE IN THE PICTURE, BUT I DO HAVE AT LEAST ONE SYRINGE WITH ME IF YOU WANT IT TO BE INSPECTED. ADDITIONAL INFORMATION PROVIDED: THE EXACT DATE OF EVENTS WAS ON 09/27/2024. MY TECH ONLY INFORMED ME OF TWO TIMES THAT THIS HAPPENED TO HER. THE EVENTS HAPPENED WITH TWO MEDICATIONS: ONDANSETRON AND MICAFUNGING. NO IMPACT ON PATIENT. IT ONLY DELAYED A LITTLE TIME IN THE PROCESS OF COMPOUNDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010533 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4221164 30382903095750

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown