BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE

    MDR report key: 14634378 · Received June 8, 2022

    Report

    Report Number
    8041187-2022-00291
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 11, 2022
    Report Date
    July 26, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    UDI-DI
    30382903057895
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. MEDICAL DEVICE TYPE: FMI. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K941562 (SYRINGE). PMA / 510(K)#: K161170 (NEEDLE). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 22-JUL-2022 H6: INVESTIGATION SUMMARY ONE SAMPLE WITHOUT PACKAGING AND TWO EMPTY BLISTER PACKAGES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION TO CHECK FOR FOREIGN MATTER INSIDE THE BARREL. EXCESSIVE LUBRICANT ON THE 1ML PLUNGER INSTEAD OF INSIDE THE BARREL WAS OBSERVED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE PACKAGING LINE WAS REVIEWED AND THERE IS NO LUBRICANT (SILICONE) USED AT THE LINE. THE 1ML SYRINGE PART IS MANUFACTURED AT BD CANAAN AND THEIR QUALITY TEAM HAS COMPLETED A SUPPLEMENTAL INVESTIGATION ON THIS NONCONFORMANCE. THE 1 ML SYRINGE PART IS MANUFACTURED AT BD CANAAN, AND THE BD CANAAN QUALITY TEAM HAS CONDUCTED A SUPPLEMENTAL INVESTIGATION ON THIS NONCONFORMANCE. THE SAMPLES WERE VISUALLY EVALUATED, AND THE SYRINGE WAS FOUND TO HAVE EXCESSIVE LUBRICANT OUTSIDE OF THE FLUID PATH ON THE PLUNGER ROD. THE INSPECTION PROCEDURES, PRODUCTION RECORDS AND TECHNICIAN LOGS WERE REVIEWED, THE PROCESS ENGINEER WAS INTERVIEWED, AND AN IN-DEPTH MACHINE EVALUATION WAS PERFORMED AS PART OF THIS INVESTIGATION. NO ISSUES AROUND THE SILICONE SYSTEM WERE NOTED IN THE PRODUCTION RECORDS OR THE TECHNICIAN LOGS. THE SILICONE GUN ON THE MACHINE WAS OBSERVED TO HAVE EXCESSIVE PLAY. THE IDEAL SET-UP IS A GUN HELD TO THE BACKING PLATE OF THE ASSEMBLY DIAL. AT THE TIME OF THE REVIEW, THE GUN WAS ABLE TO SLIDE LATERALLY ABOUT A QUARTER OF AN INCH. IT WAS ALSO OBSERVED THAT THE SILICONE GUN PURGE FUNCTION WAS DIRECTLY ACCESSIBLE ON THE HUMAN-MACHINE INTERFACE THAT OPERATORS HANDLE DAILY. THIS FUNCTION EXPELS AIR AND SILICONE FROM THE GUN AND ITS ASSOCIATED HOSE. THIS IS A FUNCTION THAT SHOULD ONLY BE ACCESSIBLE TO AUTHORIZED TECHNICIANS AS MISUSE CAN LEAD TO QUALITY ISSUES AROUND SILICONIZATION, ESPECIALLY IF MACHINE DIALS ARE NOT CLEANED POST PURGING, OR REMOVED PRIOR TO PURGING. THE ADJUSTMENT PROCEDURE FOR THE SILICONE SYSTEM ALSO DID NOT CAPTURE POST-ADJUSTMENT QUALIFICATIONS FOR THE SILICONE GUN PURGE FUNCTION. ENSURING THE ASSEMBLY SYSTEM IS CLEAN OF EXCESS LUBRICANT IS ESSENTIAL IN ENSURING QUALITY PRODUCT POST PURGE. A TRIAL WAS PERFORMED ON THE MACHINE TO REPLICATE THE DEFECT. IT WAS NOTED THAT THE MACHINE WOULD RUN WHILE THE GUN WAS IN A PURGE STATE. ADDITIONALLY, IT WAS FOUND THAT AFTER PURGING THE SILICONE GUN AND NOT PROPERLY CLEANING THE MACHINE DIALS BEFORE RETURNING TO PRODUCTION THE COMPLAINT DEFECT WOULD OCCUR. THE POTENTIAL ROOT CAUSES FOR THE EXCESSIVE SILICONE DEFECT WERE DETERMINED TO BE IMPROPER POSITIONING OF THE SILICONE GUN LEADING TO OVERSPRAY ON THE BARREL FLANGES AND THE MACHINE DIAL, EXCESSIVE SILICONE PRESENCE DUE TO THE MISUSE OF THE SILICONE GUN PURGE FUNCTION, INADEQUATE CAPTURE, AND CONFLICTION IN INSPECTION PROCEDURES FOR SILICONE OUTSIDE OF THE FLUID PATH, AND IMPROPER ADJUSTMENT REQUIREMENTS FOR SILICONE PURGE FUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST STATED CONSUMER REPORTED SEEING CLEAR LIQUID NEAR STOPPER PRIOR TO INJECTION. STATED, CONSUMER WAS CONCERNED WITH PUSHING CLEAR LIQUID INTO VIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE.   THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST STATED CONSUMER REPORTED SEEING CLEAR LIQUID NEAR STOPPER PRIOR TO INJECTION. STATED, CONSUMER WAS CONCERNED WITH PUSHING CLEAR LIQUID INTO VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290334 BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 305789 1204099 30382903057895

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown