BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML S/T W/NDL 27X1/2 RB

    MDR report key: 18832523 · Received March 4, 2024

    Report

    Report Number
    1213809-2024-00141
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    February 12, 2024
    Report Date
    September 4, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096238
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    100 SAMPLES WERE RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO EXAMINE THE SAMPLES FROM BATCH 3143581 REGARDING ITEM 309623. THE SAMPLES CAME IN SEALED PACKAGING BLISTERS. VISUAL INSPECTION WAS PERFORMED, NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. 32 SAMPLES WERE RANDOMLY SELECTED. EACH SAMPLE WAS TESTED FOR NEEDLE PULL TEST. THE VALUES WERE BETWEEN 3.6LBS TO 4.0LBS, WHICH FALLS WITHIN THE SPECIFICATION RANGE. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS, THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH THE REPORTED SYMPTOM NOT CONFIRMED, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3143581 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. 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

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 27X1/2 RB NEEDLE PULLED OUT OF HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAFETY CONCERNS INCLUDE THAT THEIR IS NOT A SAFETY THEIR IS JUST A CAP THE NEEDLE TIP COMES OFF VERY EASILY THEY HAVE "EXPLODED" THE NEEDLE AND TIP COME APART EASILY WITH A LITTLE BIT OF PRESSURE VERY FLIMSY. I HAVE HEARD FROM MULTIPLE NURSES THAT THEY HAVE POKED THEMSELVES WHEN TRYING TO REMOVE THE CAP, THAT THE NEED COMES OFF THE SYRINGE AND STAYS IN THE PATIENT WHILE THE MEDICATION IS SPRAYED ON THE PATIENT AND NURSE. AT THIS TIME WE HAVE PULLED THIS PRODUCT FROM OUR WAREHOUSE AND QUARANTINED IT UNTIL FURTHER ADVISEMENT FROM THE MANUFACTURER AND MOST OF THE FLOORS ARE NOW REQUESTING THE PRODUCT BE REMOVED FROM THEIR STOCK. PLEASE ADVISE ON HOW TO COMPLETE A QUALITY COMPLAINT WITH BD. WE HAVE LOCATED A SUB AND WILL BE BRINGING THAT PRODUCT IN SHORTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137735 BD SYRINGE 1ML S/T W/NDL 27X1/2 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3143581 30382903096238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown