BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 8804935 · Received July 18, 2019

    Report

    Report Number
    1213809-2019-00761
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 19, 2019
    Report Date
    August 12, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED, BUT WERE NOT CONFIRMED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 8340918, D.4. MEDICAL DEVICE EXPIRATION DATE: 11/30/2023, H.4. DEVICE MANUFACTURE DATE: 12/6/2018, D.4. MEDICAL DEVICE LOT #: 9002961, D.4. MEDICAL DEVICE EXPIRATION DATE: 12/31/2023 AND H.4. DEVICE MANUFACTURE DATE: 1/2/2019. H.6. INVESTIGATION SUMMARY: ONE PHOTO, ONE CONVENIENCE TRAY AND ONE LOOSE 10ML SYRINGE WERE RECEIVED AND EVALUATED. IT WAS OBSERVED IN THE PHOTO AND LOOSE SYRINGE, THERE WAS A BROWN FOREIGN MATTER PARTICLE EMBEDDED NEAR THE TOP OF THE PLUNGER ROD. IT APPEARED TO BE BURNT PLASTIC AND WAS LARGER THAN LEVEL 3 IN SIZE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. THE CONVENIENCE TRAY WAS OBSERVED TO HAVE A DARK FOREIGN MATTER FIBER ATTACHED TO THE WALL OF THE TRAY. IT APPEARED TO BE A STRAND OF HAIR AND WAS LARGER THAN LEVEL 3 IN SIZE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FM IS MOST LIKELY DEGRADED PLASTIC. THIS 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 FOREIGN MATTER IN THE TRAY IS ASSOCIATED WITH THE PACKAGING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCHES 8340918 AND 9002961 ARE 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 TWO PROVIDED LOT NUMBER (S) THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD 10ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PARTICULATE WAS NOTICED INSIDE A SYRINGE EITHER FROM LOT 8340918 OR LOT 9002961. THE WAS FOUND INSIDE OUR STERILE HOODS DURING A FILL.".

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD 10ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PARTICULATE WAS NOTICED INSIDE A SYRINGE EITHER FROM LOT 8340918 OR LOT 9002961. THE WAS FOUND INSIDE OUR STERILE HOODS DURING A FILL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599252 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other