BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7848792 · Received September 5, 2018

    Report

    Report Number
    1213809-2018-00581
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    August 8, 2018
    Report Date
    October 3, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES/PHOTOS RECEIVED, THEREFORE DEFECTS NOT CONFIRMED. ACCORDING TO THE EMAIL COMMUNICATIONS RECEIVED, THE SAMPLES WERE REPORTED TO CONTAIN SILICONE. IF THAT IS CORRECT, 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. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE TWO PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: ROOT CAUSE NOT DEFINED SINCE SAMPLES/PHOTOS WERE NOT RECEIVED TO CONFIRM THE PRODUCT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGES WITH LUER-LOK¿ TIPS, HAD VISIBLE OILY RESIDUAL IN THEM. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8002708, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, DEVICE MANUFACTURE DATE: 2018-01-02. MEDICAL DEVICE LOT #: 8088518, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31 , DEVICE MANUFACTURE DATE: 2018-03-29. (B)(6). 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 BEFORE USE OF THE BD SYRINGES WITH LUER-LOK¿ TIPS, HAD VISIBLE OILY RESIDUAL IN THEM. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687068 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other