BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 15691845 · Received October 28, 2022

    Report

    Report Number
    1213809-2022-00820
    Event Type
    Malfunction
    Date Received
    October 28, 2022
    Date of Event
    October 3, 2022
    Report Date
    January 3, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903010295
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 19-DEC-2022. H6: INVESTIGATION SUMMARY: ONE HUNDRED SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, FORTY-SEVEN SAMPLES WERE OBSERVED TO HAVE EXCESSIVE SILICONE WHICH WAS NON-CONFORMING PER PRODUCT SPECIFICATION. PLEASE NOTE THAT SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. POTENTIAL ROOT CAUSE FOR THE EXCESSIVE SILICONE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. SINCE PRODUCTION OF THE COMPLAINT BATCHES ADDITIONAL REQUIREMENTS HAVE BEEN PUT IN PLACE AROUND POST ADJUSTMENT QUALIFICATIONS TO THE SILICONE SYSTEM THAT MUST BE RECORDED IN THE DEVICE HISTORY RECORD TO ENSURE QUALITY OF PRODUCT POST MECHANICAL OR ELECTRICAL ADJUSTMENT. NO FURTHER CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0142212 AND 1152292. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0142212. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2025. DEVICE MANUFACTURE DATE: 21-MAY-2020. MEDICAL DEVICE LOT #: 1152292. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2026. DEVICE MANUFACTURE DATE: 01-JUN-2021. 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 · 0

    IT WAS REPORTED THAT 1 BD LUER-LOK¿ TIP SYRINGE EACH FROM LOTS 0142212 AND 1152292 HAD SILICONE OIL IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "JUST RECEIVED ANOTHER COMPLAINT FROM ANOTHER CUSTOMER REGARDING SILICONE OIL IN THE 10ML BD LUER-LOK SYRINGE (ITEM NO. 301029)."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD LUER-LOK¿ TIP SYRINGE EACH FROM LOTS 0142212 AND 1152292 HAD SILICONE OIL IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "JUST RECEIVED ANOTHER COMPLAINT FROM ANOTHER CUSTOMER REGARDING SILICONE OIL IN THE 10ML BD LUER-LOK SYRINGE (ITEM NO. 301029)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2881407 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H10 00382903010295

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown