BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 9355203 · Received November 21, 2019

    Report

    Report Number
    1213809-2019-01158
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 6, 2019
    Report Date
    January 28, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A SINGLE LOOSE 1ML LL SYRINGE WAS RECEIVED, AS WELL AS TWO OPENED EMPTY BLISTER PACKAGES FROM BATCH#: 9142583 (P/N: 309628). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE BARREL WAS OBSERVED TO HAVE BROWN FOREIGN MATTER MARKS BETWEEN 0.4 AND 1ML SCALE MARKINGS. THE BROWN MARKS WERE EMBEDDED IN THE PLASTIC, LARGER THAN LEVEL 3 IN SIZE AND REJECTABLE PER PRODUCT SPECIFICATION. THE BARREL WAS IDENTIFIED TO BE FROM CAVITY 42 WITH NO MOLD # PRINTED. 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. PER PROCEDURE, AFTER START UP, ALL MOLDED PARTS ARE SCRAPPED UNTIL NO DEGRADED PLASTIC IS OBSERVED. IF THIS IS NOT PERFORMED THOROUGHLY A PIECE WITH THIS CONDITION CAN GET THROUGH. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING HANDLING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH: 9142583 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A "DARK BROWN SPOT" WAS FOUND ON THE BD SYRINGE LUER-LOK¿ TIP BARREL BEFORE USE. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DARK BROWN SPOT SHOWN ON PLUNGER BARREL. PHARM TECH NOTICED DEFECT BEFORE USE."

    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 A "DARK BROWN SPOT" WAS FOUND ON THE BD SYRINGE LUER-LOK¿ TIP BARREL BEFORE USE. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DARK BROWN SPOT SHOWN ON PLUNGER BARREL. PHARM TECH NOTICED DEFECT BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154142 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9142583 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other