BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 8186840 · Received December 20, 2018

    Report

    Report Number
    9610847-2018-00427
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 28, 2018
    Report Date
    January 23, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMI
    UDI-DI
    00382903057863
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE THERE WAS AN ISSUE WITH SYRINGE NOT BEING FULLY TIGHT WITH NEEDLE. IT WAS REPORTED THAT 50 DEVICES WERE AFFECTED. INVESTIGATION SUMMARY: THE SAMPLES RECEIVED FROM THE CUSTOMER WERE VISUALLY INSPECTED FOR ANY DAMAGE THAT THEY COULD HAVE AND THE ONLY PLACE FOUND WITH SOME TEARING WAS THE AREA OF THE LUER CONNECTION ON BOTH NEEDLES RECEIVED. THIS TEAR WAS DONE AT THE MOMENT THE NEEDLE AND THE SYRINGE WERE ASSEMBLED TOGETHER AND WHEN THE LUER CONNECTION WAS TIGHTENED THE TREADS WERE LOOSED, THIS IS THE CONDITION THAT THE CUSTOMER FIND ON THE MATERIAL. WITH THIS CONDITION WE CAN CONFIRM THE ISSUE STATED BY THE CUSTOMER ON THE TWO SAMPLES RECEIVED, AFTER THAT WE ASSEMBLED THE RETAIN SAMPLES WE HAVE AND PERFORM THE SAME TEST, WE ASSEMBLED 10 PIECES OF THE NEEDLE AND THE SYRINGE BUT ON THIS CASE WE DID NOT FIND ANY FAILURE AS THE ONE SHOWED ON THE SAMPLES RECEIVED FROM THE CUSTOMER, WE CAN ASSIGN THIS ISSUE AS A MATERIAL DEFECT, DUE THAT OUR PROCESS IT IS ONLY PACKAGING, WE PLACE THE NEEDLE AND THE SYRINGE ON A BLISTER AND THEN IT IS SEALED AND PACKED, WE DO NOT PERFORM ANY KIND OF TEST DURING THIS PROCESS. THE DEFECT STATED BY THE CUSTOMER IT IS CONFIRMED. REVIEWING OUR PFMEA¿S RM5788, THERE ARE PROPER CONTROLS IN PLACE TO DETECT PACKAGING PRODUCT MALFUNCTIONS. WE COULD NOT DETERMINE THE ROOT CAUSE AS A MANUFACTURING DEFECT, IT CAN BE ASSIGN IT AS A MATERIAL OR END USER ISSUE, DUE THAT DURING THE ASSEMBLY OF THE RETENTION SAMPLES WE COULD NOT REPLICATE THE DEFECT FOUND BY THE CUSTOMER. MATERIAL 305224 WITH LOT NUMBER 8221608 WAS MANUFACTURED ON AUGUST 21, 2018. ACCORDING TO SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED. DURING MANUFACTURING OF THIS LOT NUMBER SEVERAL INSPECTION WERE PERFORMED TO THE MATERIAL AND NO SIMILAR ISSUES TO THE ONE STATED BY THE CUSTOMER WERE FOUND. THESE INSPECTIONS WERE PERFORMED BY THE QA TECH AND PRODUCTION PERSONNEL, DURING THE INSPECTIONS NO ISSUES WERE FOUND. ALL RELEVANT INFORMATION DURING THE DHR REVIEW SHOWN THAT MEET ALL ESTABLISHED MANUFACTURING CRITERIA.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE THERE WAS AN ISSUE WITH SYRINGE NOT BEING FULLY TIGHT WITH NEEDLE. IT WAS REPORTED THAT 50 DEVICES WERE AFFECTED.

    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 WITH THE USE OF THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE THERE WAS AN ISSUE WITH SYRINGE NOT BEING FULLY TIGHT WITH NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023699 BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8221608 00382903057863

    Patients

    Seq Age Sex Outcome Treatment
    1 Other