BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 ML BD LUER-LOK TIP SYRINGE

    MDR report key: 10538728 · Received September 15, 2020

    Report

    Report Number
    1911916-2020-00869
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 20, 2019
    Report Date
    August 31, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    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 REVIEW WAS COMPLETED FOR MATERIAL NUMBER 302832 AND LOT NUMBER 0052748. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, TWO PHYSICAL SAMPLES AND THREE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE TWO PHYSICAL SAMPLES CAME IN A (B)(4) PLASTIC BAG WITH NO PACKAGING BLISTER. EACH HAD A CONNECTED NEEDLE ASSEMBLY AND HAVE BEEN USED. A VISUAL INSPECTION WAS PERFORMED WITH A 30X MICROSCOPE AND A FINE FOREIGN MATTER WAS OBSERVED ADHERED TO THE BOTTOM OF EACH OF THE STOPPERS. THE SOURCE OF THE FINE FOREIGN MATTER IS UNKNOWN AND BECAUSE OF ITS SIZE NO FURTHER ANALYSIS COULD BE PERFORMED. IN THE THREE PHOTOS PROVIDED, TWO SHOW THE SAMPLES RECEIVED AND, IN THE THIRD PHOTO, ONE OF THE SAMPLES IN THE PACKAGING BOX. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. PROBABLE ROOT CAUSE COULD NOT BE OFFERED. BECAUSE OF THE SIZE THE FOREIGN MATTER COULD NOT BE ANALYZE. THE SAMPLES HAVE BEEN USED. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 30 ML BD LUER-LOK¿ TIP SYRINGE HAD FOREIGN MATTER IN THE SYRINGE. THIS OCCURRED ON 2 OCCASIONS 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
    1002342 30 ML BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302832 0052748 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other