BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7881419 · Received September 17, 2018

    Report

    Report Number
    1213809-2018-00621
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Date of Event
    August 27, 2018
    Report Date
    October 8, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A PHOTO WAS RECEIVED AND EVALUATED. IT DEPICTS AN UP CLOSE IMAGE OF A PART OF A SYRINGE, POSSIBLY A 10ML. THE STOPPER IS PULLED BACK SLIGHTLY. SILICONE APPEARS TO BE VISIBLE ON THE STOPPER AND ROOF OF THE BARREL. WHETHER THE AMOUNT OF SILICONE MEETS OR EXCEEDS THE SPECIFICATION CANNOT BE DETERMINED FROM THE PHOTO PROVIDED. PHYSICAL SAMPLES IN A FORM OF VARIOUS SYRINGES FROM MULTIPLE BATCHES AND PRODUCTS WERE RECEIVED IN A BOX SEPARATED INTO TWO GARMENT BAGS. ALSO CONTAINED IN THE BAG WERE ONE LOOSE 20ML SYRINGE, ONE LOOSE 3ML SYRINGE, ONE LOOSE 5ML SYRINGE, ONE PACKAGED 5ML SYRINGE FROM BATCH #8155944 (P/N 309646). GARMENT BAG 1: 4 LOOSE 10ML SYRINGES. 18 SEALED 10ML PACKAGED SYRINGES FROM BATCH #8033683 (P/N 302995). 44 SEALED 10ML PACKAGED SYRINGES FROM BATCH #8067721 (P/N 302995). A SMALL BIOHAZARD BAG WITH 6 OPEN PACKAGED 10ML SYRINGES (P/N 302995) ¿ 4 FROM BATCH #8067721 AND 2 FROM BATCH # 8033683. GARMENT BAG 2 CONTAINED: 16 SEALED 10ML PACKAGED SYRINGES FROM BATCH #8033683 (P/N 302995), 59 SEALED 10ML PACKAGED SYRINGES FROM BATCH #8067721 (P/N 302995). 1 PACKAGED 5ML SYRINGE FROM BATCH 8064640 (P/N 309646). ALL 10ML SYRINGES CONTAINED IN BOTH GARMENT BAGS WERE VISUALLY EVALUATED. THE SYRINGES WERE FOUND TO HAVE NO VISUAL DEFECTS. MOST SYRINGES WERE FOUND TO HAVE A SMALL AMOUNT OF VISIBLE SILICONE ON THE STOPPER OR ROOF OF THE BARREL. NO STRINGING AND NO POOLING OF SILICONE WAS OBSERVED. THE SMALL AMOUNT OBSERVED IS A NORMAL AND EXPECTED AMOUNT FOR THIS PRODUCT PER PRODUCT SPECIFICATION. THE LOOSE AND PACKAGED 5ML SYRINGES, THOUGH NOT PART OF THE COMPLAINT WERE ALSO EVALUATED AND HAD NO EXCESS SILICONE OBSERVED. THE AMOUNT AND APPEARANCE OF THE SILICONE IN THE SAMPLES MEETS OUR PRODUCT SPECIFICATION OF 2.0 TO 7.0 MG FOR THE 10ML PRODUCT. FURTHERMORE, THE BD PRODUCT SPEC IS TIED TO THE LATEST UPDATE FOR SYRINGES WHICH SPECIFIES THAT SILICONE APPEARANCE SHALL BE MINIMIZED. THE SAMPLES RETURNED MEET THAT REQUIREMENT. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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. 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 A CLEAR, FOREIGN LIQUID WAS NOTICED IN THE BD LUER-LOK¿ TIP SYRINGES. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEAR, FOREIGN LIQUID WAS NOTICED IN THE BD LUER-LOK¿ TIP SYRINGES. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720804 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8033683 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other