BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE ECLIPSE 18X1-1/2 RB

    MDR report key: 8965851 · Received September 5, 2019

    Report

    Report Number
    8041187-2019-00705
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    August 17, 2019
    Report Date
    September 27, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057666
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: PHOTO EVALUATION ¿ 1 PHOTO WAS RECEIVED FOR INVESTIGATION ¿ OBSERVED GREEN FOREIGN MATTER ON THE BODY OF THE CANNULA. SAMPLE EVALUATION ¿ 1 ACTUAL SAMPLE WITH NO PACKAGING WAS RECEIVED FOR INVESTIGATION ¿ THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION TO CHECK FOR FOREIGN MATTER. ¿ ONE LOOSE GREEN FOREIGN MATTER WAS OBSERVED ON THE BODY OF THE CANNULA ¿ THE GREEN FOREIGN MATTER WAS SENT FOR FTIR TEST TO DETERMINE THE FOREIGN MATTER TYPE. ¿ THE FTIR RESULTS SHOWS THAT THE GREEN FOREIGN MATTER SPECTRUM MATCHES REASONABLY WITH THAT OF POLYCARBONATE ¿ MATERIAL WAS COLLECTED FROM THE GREEN RACK USED IN THE ASSEMBLY PROCESS TO COMPARE WITH THE GREEN FOREIGN MATTER. ¿ THE FTIR RESULTS SHOWS THAT THE GREEN RACK MATERIAL SPECTRUM MATCHES REASONABLY WITH THAT OF POLYCARBONATE ¿ BOTH THE GREEN FOREIGN MATTER AND GREEN RACK MATERIAL SPECTRUM IS SIMILAR THE PROBABLE CAUSE COULD BE OVER TIME, THE GREEN RACK IS SUBJECTED TO WEAR AND TEAR. THIS COULD HAVE CAUSED THE DEBRIS FROM THE RACK PIN TO BE TRANSPORTED TO THE CANNULA DURING PRODUCTION. THERE IS A 3 MONTHLY PREVENTIVE MAINTENANCE IN PLACE TO REMOVE THE OLD RACK AND REPLACE WITH THE NEW RACK. THE ASSEMBLED NEEDLE WAS PRODUCED IN FEB 2019 WHICH IS BEFORE THE REPLACEMENT OF THE NEW RACK IN MAR 2019 DHR: ¿ THERE WERE NO FOREIGN MATTER ON CANNULA REJECTS AT THE OUTGOING INSPECTION. ¿ NO QUALITY NOTIFICATIONS WERE RAISED FOR PAST 12 MONTHS ON SIMILAR REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE ECLIPSE 18X1-1/2 RB EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO 305766 BATCH NO. 9042967. IN THE CATH LAB TODAY, I WAS ABOUT TO GIVE A DRUG TO THE STERILE TABLE THROUGH THIS NEEDLE WHEN I NOTICED THE GREEN GOOP ON THE END. THE NEEDLE CAME OUT OF THE PACKAGE LIKE THIS. WE DID NOT RETAIN THE PACKAGE AS IT HAD ALREADY BEEN THROWN IN THE TRASH WITH MULTIPLE OTHER 18 GAUGE NEEDLE PACKAGES AND IT WOULD HAVE BEEN IMPOSSIBLE TO KNOW WHICH PACKAGE IT CAME FROM.

    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 THAT THE NEEDLE ECLIPSE 18 X 1-1/2 RB EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO 305766, BATCH NO. 9042967. IN THE CATH LAB TODAY, I WAS ABOUT TO GIVE A DRUG TO THE STERILE TABLE THROUGH THIS NEEDLE WHEN I NOTICED THE GREEN GOOP ON THE END. THE NEEDLE CAME OUT OF THE PACKAGE LIKE THIS. WE DID NOT RETAIN THE PACKAGE AS IT HAD ALREADY BEEN THROWN IN THE TRASH WITH MULTIPLE OTHER 18 GAUGE NEEDLE PACKAGES AND IT WOULD HAVE BEEN IMPOSSIBLE TO KNOW WHICH PACKAGE IT CAME FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761881 NEEDLE ECLIPSE 18X1-1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 9042967 30382903057666

    Patients

    Seq Age Sex Outcome Treatment
    1 Other