BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ BLUNT FILL NEEDLE

    MDR report key: 8104188 · Received November 26, 2018

    Report

    Report Number
    1213809-2018-00813
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 6, 2018
    Report Date
    January 17, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903050605
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SEALED PACKAGED AND TWO OPENED PACKAGED 3ML SYRINGES WITH NEEDLE WERE RECEIVED, CONFIRMED TO BE FROM BATCH #8219569 (P/N 305060). A NOTE WAS ATTACHED TO ONE PACKAGE INDICATING A LUBRICANT ISSUE. THREE PIECE OF TOP WEB WERE ALSO RECEIVED FROM BATCH #8122538 AND A NOTE INDICATING AN ISSUE WITH A STOPPER FOR THAT BATCH. NO SAMPLES WERE PROVIDED FOR BATCH #8122538 TO EVALUATE POTENTIAL STOPPER DEFECTS, THEREFORE THE STOPPER DEFECT COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: THE SAMPLES WERE VISUALLY EVALUATED. THE SYRINGE IN A PACKAGE WITH A NOTE ATTACHED WAS FOUND TO HAVE EXCESSIVE SILICONE PRESENCE ON THE STOPPER. THE SILICONE WAS STRINGING AND POOLING FROM THE BARREL¿S ROOF AS THE STOPPER WAS PULLED BACK. EXCESS SILICONE IS REJECTABLE PER PRODUCT SPECIFICATION. TWO SAMPLES IN PACKAGES WITHOUT NOTES HAD NORMAL AND EXPECTED AMOUNT OF SILICONE PRESENCE 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. 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. ROOT CAUSE DESCRIPTION: POTENTIAL ROOT CAUSE FOR THE EXCESS SILICONE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. SINCE NO SAMPLES DISPLAYING THE REPORTED STOPPER CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED. RATIONALE: NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. SINCE NO SAMPLES DISPLAYING THE REPORTED STOPPER CONDITION WERE RECEIVED CORRECTIVE ACTIONS ARE NOT NECESSARY. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "LUBRICANT" WAS NOTICED IN THE SYRINGE BARREL OF THE BD LUER-LOK¿ BLUNT FILL NEEDLE, AND THE STOPPER HAD A LOOSE CLOSURE THAT CAUSED LEAKAGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8219569; MEDICAL DEVICE EXPIRATION DATE: 2023-07-31; DEVICE MANUFACTURE DATE: 2018-08-07. MEDICAL DEVICE LOT #: 8122538; MEDICAL DEVICE EXPIRATION DATE: 2023-04-30; DEVICE MANUFACTURE DATE: 2018-05-02. 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 "LUBRICANT" WAS NOTICED IN THE SYRINGE BARREL OF THE BD LUER-LOK¿ BLUNT FILL NEEDLE, AND THE STOPPER HAD A LOOSE CLOSURE THAT CAUSED LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940603 BD LUER-LOK¿ BLUNT FILL NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10. 30382903050605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other