BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 10752412 · Received October 28, 2020

    Report

    Report Number
    1911916-2020-00988
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 5, 2020
    Report Date
    October 19, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0062259. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, 2 PICTURES AND 2 PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION OF THE PHYSICAL SAMPLES WITH A 10X MAGNIFYING LENS AN A 30X MICROSCOPE WAS PERFORMED AND UNKNOWN MATTER WAS OBSERVED AND ADHERED TO THE RUBBER STOPPER. THE SAMPLES WERE SENT TO THE LAB FOR FURTHER ANALYSIS. THE PICTURE SAMPLES PROVIDED SHOW A SYRINGE WITH A RUBBER STOPPER AND A WRITTEN CIRCLE HIGHLIGHTING THE FOREIGN MATTER. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE WITH THE SAMPLES AND PHOTOS PROVIDED. ROOT CAUSE DESCRIPTION: THE LAB PROVIDED RESULTS THAT THE FOREIGN MATTER WAS MEDICAL GRADE SILICONE OIL WHICH IS USED TO LUBRICATE THE BARREL AND STOPPER DURING THE MANUFACTURING PROCESS. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND IN 2 BD LUER-LOK¿ TIP SYRINGES' STOPPERS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FINE WHITE FOREIGN MATERIAL WERE FOUND IN THE STOPPER OF THE SYRINGE WHILE PREPARING EXPENSIVE ANTICANCER DRUGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217786 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 0062259 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1