BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13470620 · Received February 7, 2022

    Report

    Report Number
    8041187-2022-00068
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    January 24, 2022
    Report Date
    February 25, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    UDI-DI
    30382903057895
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 2/9/2022. INVESTIGATION: FIVE SAMPLES WITHOUT PACKAGING AND TWO EMPTY UNIT PACKAGES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION TO CHECK FOR FOREIGN MATTER AND SCALE MARKING ISSUES. FROM THE RETURNED SAMPLES, TWO SAMPLES WERE OBSERVED WITH BROWN EMBEDDED FOREIGN MATTER, ONE SAMPLE WAS OBSERVED WITH A MISSING SCALE MARKING, ONE SAMPLE WAS OBSERVED WITH VOID / BUBBLES IN THE SYRINGE BARREL, AND ONE SAMPLE WITH NO ABNORMALITIES. 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. AS THE SYRINGE PART IS MANUFACTURED AT BD CANAAN, THE QUALITY TEAM THERE COMPLETED A SUPPLEMENTAL INVESTIGATION. AFTER VISUAL EVALUATION OF THE SAMPLES, THE TWO SAMPLES WERE OBSERVED WITH EMBEDDED BROWNISH / YELLOW FOREIGN MATTER ON SEVERAL AREAS OF THE BARREL. THE FOREIGN MATTER APPEARS TO BE DEGRADED PLASTIC. ONE SAMPLE WAS OBSERVED TO HAVE SEVERAL EMBEDDED AIR BUBBLES NEAR THE COLLAR OF THE SYRINGE. ONE SAMPLE WAS MISSING NEARLY THE ENTIRETY OF THE PRINTED SCALE WITH ONLY THE VERBIAGE, BD LOGO, AND SINGLE USE ONLY SYMBOL PRESENT. THE FINAL SAMPLE APPEARED TO HAVE A JAMMED STOPPER WHICH WAS ANGLED UP TOWARDS THE BARREL FLANGE. THE OBSERVED CONDITIONS WERE ALL NON-CONFORMING PER PRODUCT. THE POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC, WHICH OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. THE POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD LUER-LOK¿ SYRINGES WITH DETACHABLE BD ECLIPSE¿ NEEDLE HAD BROWN FOREIGN MATTER INSIDE THEM. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "2 SYRINGES LOOK LIKE THERE IS SOME KIND OF BROWN SUBSTANCE ON THE INSIDE,".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD LUER-LOK¿ SYRINGES WITH DETACHABLE BD ECLIPSE¿ NEEDLE HAD BROWN FOREIGN MATTER INSIDE THEM. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "2 SYRINGES LOOK LIKE THERE IS SOME KIND OF BROWN SUBSTANCE ON THE INSIDE,"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504857 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