BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 8206868 · Received December 31, 2018

    Report

    Report Number
    9610847-2018-00446
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Date of Event
    November 27, 2018
    Report Date
    January 8, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B.5. DESCRIBE EVENT OR PROBLEM: THE CUSTOMER CLAIMED THAT THERE WAS DIRT ON THE ON THE BD CONNECTA¿ STOPCOCK CAP WHERE NEEDLE INJECTED. THE AFFECTED QUANTITY WAS 1500PCS, IN WHICH 1123PCS WERE RETURNED TO THE DISTRIBUTOR. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY THE FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBERS 8037902 & 8110572.OUR RECORDS DETERMINED THAT THIS IS THE ONLY INSTANCE OF FOREIGN MATERIAL BEING REPORTED IN EITHER LOT. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, BOTH LOST WERE ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. INVESTIGATION CONCLUSION: A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING BY THE MANUFACTURER. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. ROOT CAUSE DESCRIPTION: WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. RATIONALE: BD WILL CONTINUE TO MONITOR THIS ISSUE AND IN CASE ANY EMERGING TREND IS DETECTED, FURTHER ACTIONS WILL BE TAKEN IF NECESSARY.

    Description of Event or Problem · 0

    THE CUSTOMER CLAIMED THAT THERE WAS DIRT ON THE ON THE BD CONNECTA¿ STOPCOCK CAP WHERE NEEDLE INJECTED. THE AFFECTED QUANTITY WAS 1500PCS, IN WHICH 1123PCS WERE RETURNED TO THE DISTRIBUTOR.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8110572, MEDICAL DEVICE EXPIRATION DATE: 2021-03-31, DEVICE MANUFACTURE DATE: 2018-06-06. MEDICAL DEVICE LOT #: 8037902 , MEDICAL DEVICE EXPIRATION DATE: 2021-01-31, DEVICE MANUFACTURE DATE: 2018-03-13. 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 THERE WAS "DIRT" ON THE BD CONNECTA¿ STOPCOCK CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044782 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other