BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LS 21X1-1/2 DN INDIA BP

    MDR report key: 8544146 · Received April 24, 2019

    Report

    Report Number
    2243072-2019-00774
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 9, 2019
    Report Date
    May 8, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE DHR WAS REVIEWED AND NO NCP OR QN WAS RAISED ON THIS LOT DURING MANUFACTURING AND PRODUCTION OF THE LOT NUMBER 9002752 UNTIL LOT RELEASE. NO CUSTOMER RETURN SAMPLE AND PHOTOGRAPH ARE AVAILABLE FOR INVESTIGATION. THE TEAM REVIEWED THE PROCESS CONTROLS OF ASSEMBLY PROCESS AND PACKAGING PROCESS. ALL PROCESS CONTROLS ARE IN PLACE. THE TEAM ALSO CHECKED THE SYRINGE TIP FORCE AS MEASURED DURING THE MANUFACTURING OF CUSTOMER REPORTED LOT 9002752 WHICH FOUND WITHIN THE SPECIFICATION LIMIT THERE ARE VARIOUS FACTORS INVOLVED IN LUER TIP DAMAGE LIKE DIMENSION LUER SLIP OF SYRINGE, TIP OUTER DIAMETER ETC. THE DIMENSION OF BARREL TIP OF RETENTION SAMPLE OF 10MLL EMERALD SYRINGE 24G ARE CHECKED AND CONFORMS WITHIN SPECIFICATION LIMIT. IT IS ALSO OBSERVED THAT 10 ML EMERALD 24G IS NOT THE RIGHT PRODUCT TO BE USED IN THE THREE WAY PORT HUB, FOR FURTHER INVESTIGATION WE WILL REQUIRE A PRACTICE DEMONSTRATION VIDEO TO COMMENT FURTHER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE 10ML LS 21X1-1/2 DN INDIA BP TIP WAS DAMAGED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2ML & 5ML SYRINGE TIP GETS STUCK IN 3WAY STOPCOCK OF DEVICE, AND TIP GETS DAMAGED BREAKED DETACHED FROM SYRINGE IN TO THE 3WAY PORT HUB.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ SYRINGE 10ML LS 21X1-1/2 DN INDIA BP TIP WAS DAMAGED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2ML & 5ML SYRINGE TIP GETS STUCK IN 3WAY STOPCOCK OF DEVICE, AND TIP GETS DAMAGED, BREAK DETACHED FROM SYRINGE IN TO THE 3WAY PORT HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340811 BD SYRINGE 10ML LS 21X1-1/2 DN INDIA BP SYRINGE FMF BECTON DICKINSON 9002752

    Patients

    Seq Age Sex Outcome Treatment
    1 Other