BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD QS SYRINGE LS

    MDR report key: 14138044 · Received April 18, 2022

    Report

    Report Number
    2243072-2022-00496
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 23, 2022
    Report Date
    May 13, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?: YES. RETURNED TO MANUFACTURER ON: 12-MAY-2022. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2021095. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY A SAMPLE WAS SUBMITTED TO AID IN OUR INVESTIGATION. UNFORTUNATELY DUE TO THE CURRENT CUSTOMS ENFORCEMENT IN CHINA, THE DEVICE COULD NOT BE RETURNED TO THE MANUFACTURING FACILITY FOR REVIEW. IN LIEU OF THE PHYSICAL DEVICE, PHOTOGRAPHS WERE TAKEN AND SUBMITTED TO THE ENGINEERING TEAM. USING THE PHOTOGRAPH OUR ENGINEERS WERE ABLE TO CONFIRM THAT THE PRINTING ON THE SYRINGE WAS SLANTED, BUT THE RETURNED UNIT LACKED THE NEEDLE COMPONENT WHICH PREVENT THEIR INVESTIGATION IN TO THIS NON-CONFORMANCE. BASED ON THESE IMAGES OUR ENGINEERS WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS RELATED TO A MISORIENTATION OF THE SYRINGE DURING THE PRINTING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD QS SYRINGE LS HAD MISALIGNED SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PROBLEM WITH GRADUATION OF 1ML SYRINGES. GRADUATION IS DIAGONAL ON MULTIPLE SYRINGES"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD QS SYRINGE LS HAD MISALIGNED SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " PROBLEM WITH GRADUATION OF 1ML SYRINGES. GRADUATION IS DIAGONAL ON MULTIPLE SYRINGES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2640181 BD QS SYRINGE LS PISTON SYRINGE FMF BECTON DICKINSON 2021095

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown