BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 10795851 · Received November 5, 2020

    Report

    Report Number
    1911916-2020-01009
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 13, 2020
    Report Date
    November 26, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653 AND LOT NUMBER 0140469. 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, FIVE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOWS SYRINGES. IN ONE OF THE PHOTOS IT CAN BE SEEN VERY CLEARLY THAT A PIECE OF A PLUNGER ROD THUMB PRESS IS INSIDE OF THE SYRINGE. THERE IS ALSO A PHOTO OF A SYRINGE WITH A FRUIT FLY IN IT. IT COULD BE POSSIBLE FOR THE PLUNGER ROD FOREIGN MATTER DEFECT TO OCCUR DURING THE SYRINGE ASSEMBLY PROCESS. IF A JAM OCCURRED AND THE PLUNGER ROD BECAME DAMAGED AT THE THUMB PRESS, THEN A PIECE OF PLASTIC COULD HAVE GONE INTO THE BARREL. THE ASSEMBLY LINE WAS INSPECTED, INCLUDING THE RAILS AND CONVEYOR, AND THERE IS A GOOD FLOW OF PRODUCT. NO PIECES OF PLASTIC WERE OBSERVED IN THE AREA. THE CUSTOMER REPORTED BUYING THESE PRODUCTS FROM A DISTRIBUTOR. IT IS UNCLEAR IF THE DISTRIBUTOR IS DOING ANY ADDITIONAL PROCESSING AFTER THE BD MANUFACTURING PROCESS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD LUER-LOK¿ TIP SYRINGE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR PHARMACY TEAM IDENTIFIED A PIECE OF PLASTIC LOCATED IN A 50ML SYRINGE (309653) FROM LOT 0140469." "CORRECTIONS: AR CODE FM ON OUTSIDE, IS NOT FOREIGN MATTER, IT IS A HOLE IN THE 20ML SYRINGE ((B)(4)). AR CODE IS FOR FM PLASTIC INSIDE SYRINGE AND FRUIT FLY."

    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.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD LUER-LOK¿ TIP SYRINGE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR PHARMACY TEAM IDENTIFIED A PIECE OF PLASTIC LOCATED IN A 50ML SYRINGE (309653) FROM LOT 0140469." "CORRECTIONS: AR CODE FM ON OUTSIDE, IS NOT FOREIGN MATTER, IT IS A HOLE IN THE 20ML SYRINGE ((B)(4)). AR CODE IS FOR FM PLASTIC INSIDE SYRINGE AND FRUIT FLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254986 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 0140469 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1