BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP DISPOSABLE SYRINGE

    MDR report key: 12832204 · Received November 17, 2021

    Report

    Report Number
    1213809-2021-00773
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 20, 2021
    Report Date
    December 3, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    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

    H.6. INVESTIGATION: THREE LOOSE 3ML SYRINGES (P/N 309657) WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. UPON EXERCISING THE PLUNGER/STOPPER ASSEMBLY LIQUID WAS OBSERVED TO BE STRINGING BETWEEN THE BARREL ROOF AND STOPPER. SOME POOLING WAS EVIDENT ON THE STOPPERS AS WELL. THE LIQUID APPEARED TO BE SILICONE LUBRICANT, OF WHICH THERE WAS AN EXCESSIVE AMOUNT PRESENT. THE OBSERVED CONDITION WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE EXCESSIVE SILICONE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH #1181523 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. 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 3 BD LUER-LOK¿ TIP DISPOSABLE SYRINGES HAD LIQUID IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PREPARING AN "EPI SPRITZER" FOR A CRITICAL PATIENT GOING ON TRANSPORT TO CT, I NOTICED THAT THERE WAS A LIQUID IN THE 3 ML SYRINGE WHEN I OPENED IT FROM THE PACKAGE AND PULLED BACK THE PLUNGER. I THEN REPEATED THIS WITH TWO OTHER 3 ML SYRINGES WHICH ALSO HAD LIQUID IN THEM. I THEN PREPARED THE MEDICATION USING A 5 ML SYRINGE RATHER THAN A 3 ML SYRINGE TO CIRCUMVENT THE ISSUE AND NOTIFIED THE APSM WHO ESCALATED TO QUALITY AND SAFETY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD LUER-LOK¿ TIP DISPOSABLE SYRINGES HAD LIQUID IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PREPARING AN "EPI SPRITZER" FOR A CRITICAL PATIENT GOING ON TRANSPORT TO CT, I NOTICED THAT THERE WAS A LIQUID IN THE 3 ML SYRINGE WHEN I OPENED IT FROM THE PACKAGE AND PULLED BACK THE PLUNGER. I THEN REPEATED THIS WITH TWO OTHER 3 ML SYRINGES WHICH ALSO HAD LIQUID IN THEM. I THEN PREPARED THE MEDICATION USING A 5 ML SYRINGE RATHER THAN A 3 ML SYRINGE TO CIRCUMVENT THE ISSUE AND NOTIFIED THE APSM WHO ESCALATED TO QUALITY AND SAFETY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726793 BD LUER-LOK¿ TIP DISPOSABLE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 1181523 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown