BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7956280 · Received October 11, 2018

    Report

    Report Number
    1213809-2018-00651
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 17, 2018
    Report Date
    November 19, 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
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTO ATTACHED WAS ALREADY EVALUATED UNDER (B)(4). FOUR SEALED 10ML PACKAGED SYRINGES WERE RECEIVED AND CONFIRMED TO BE FROM BATCH #8002664 (P/N 302995). THE SAMPLES WERE VISUALLY EVALUATED. NO VISUAL DEFECTS WERE OBSERVED. THE ¿GEL-LIKE SUBSTANCE¿ OBSERVED BY THE END USER IS NORMAL SILICONE CONTENT FROM THE SYRINGE ASSEMBLY PROCESS. THE OBSERVED AMOUNT OF SILICONE IS NORMAL AND EXPECTED AMOUNT FOR THIS PRODUCT PER PRODUCT SPECIFICATION. ONE VIDEO WAS RECEIVED AND EVALUATED. TWO 10ML SYRINGES ARE SHOWN IN THE VIDEO. BOTH SYRINGES SHOW CLEAR SIGNS OF EXCESS SILICONE INSIDE THE BARREL. EACH SYRINGE HAS ITS PLUNGER TAKEN OUT AND HAS EXCESS SILICONE VISIBLE ON THE STOPPER. THE EXCESS SILICONE OBSERVED IS REJECTABLE 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 FOR EXCESS SILICONE IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE EXTREMELY LOW CONFIRMED NUMBER OF DEFECTS FOR THE 2 REPORTED BATCHES AT THIS TIME. A 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD SYRINGE LUER-LOK TIP THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8002664; MEDICAL DEVICE EXPIRATION DATE: 2022-12-31; DEVICE MANUFACTURE DATE: 2018-01-02. MEDICAL DEVICE LOT #: 7178955; MEDICAL DEVICE EXPIRATION DATE: 2022-06-30; DEVICE MANUFACTURE DATE: 2017-06-27. 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 WITH THE USE OF THE BD SYRINGE LUER-LOK¿ TIP THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797181 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other