BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP

    MDR report key: 15460341 · Received September 21, 2022

    Report

    Report Number
    1213809-2022-00603
    Event Type
    Malfunction
    Date Received
    September 21, 2022
    Date of Event
    August 26, 2022
    Report Date
    October 29, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096497
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 25-OCT-2022. H6: INVESTIGATION SUMMARY TWENTY-EIGHT SAMPLES IN SEALED PACKAGES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT ALL SAMPLE HAVE ACCEPTABLE AMOUNT OF SILICONE WHICH IS USED IN THE MANUFACTURING PROCESS. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE PRODUCT, 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. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. SINCE THE REPORTED DEFECT NOT A TRUE DEFECT, NO CORRECTIVE ACTIONS ARE NECESSARY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2130262. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON THE BD PLASTIPACK (IV) SYRINGES, THERE IS OOZING AT THE LEVEL OF THE BLACK RUBBER. TO THE TOUCH, IT IS STICKY. IT IS VERY DISTURBING KNOWING THAT IF WE USE THEM IN IV, THERE WILL UNDOUBTEDLY BE MIGRATION OF THE FOLLOWING SUBSTANCE TOWARDS THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON THE BD PLASTIPACK (IV) SYRINGES, THERE IS OOZING AT THE LEVEL OF THE BLACK RUBBER. TO THE TOUCH, IT IS STICKY. IT IS VERY DISTURBING KNOWING THAT IF WE USE THEM IN IV, THERE WILL UNDOUBTEDLY BE MIGRATION OF THE FOLLOWING SUBSTANCE TOWARDS THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2727224 BD PLASTIPAK¿ SYRINGES WITH LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2130262 00382903096497

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown