BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LUER-LOK¿ TIP

    MDR report key: 6956205 · Received October 17, 2017

    Report

    Report Number
    1213809-2017-00196
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 28, 2017
    Report Date
    December 7, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903029952
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: FOUR SEALED 10ML PACKAGED SYRINGES WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7212573 (P/N 302995). THE SAMPLES WERE VISUALLY EVALUATED. THE PACKAGES WERE INSPECTED FOR ANY LIQUID DAMAGE ¿ NO SIGNS OF DEFECTS OR DAMAGE FOUND. THE PACKAGES WERE THEN OPENED AND EACH SAMPLE WAS INDIVIDUALLY EVALUATED. NO LIQUID WAS FOUND IN OR AROUND THE SYRINGES. A SMALL AMOUNT OF SILICONE COULD BE SEEN ON THE STOPPERS EDGES AND NEAR THEIR CENTERS WHERE THE STOPPERS TOUCH THE BARREL¿S ROOF. THE AMOUNT OBSERVED WAS A NORMAL AND EXPECTED AMOUNT OF SILICONE FOR THIS PRODUCT. NO STRINGING AND NO POOLING OF SILICONE WAS OBSERVED. THE SMALL AMOUNT IS REQUIRED FOR THE PRODUCT TO FUNCTION PROPERLY. 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. DHR REVIEW FOR BATCH 7212573 (P/N 302995): PKG BATCH MANUFACTURING DATE: 08/24/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7212573 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. THREE SUB-ASSEMBLY BATCHES WENT INTO THE FINAL PACKAGING BATCH 7212573, WHICH WERE MANUFACTURED 8/23 ¿ 8/25/2017. NO ISSUES AND NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT WERE NOTED DURING THE MANUFACTURE OF THOSE BATCHES. A TOTAL OF 11 SILICONE WEIGHT TESTS WERE RECORDED PERFORMED AS PER REQUIREMENT WITH ACCEPTABLE RESULTS WITH NO ISSUES NOTED. INVESTIGATION CONCLUSION: BASED ON THE SAMPLE EVALUATION: UNCONFIRMED: BD CANAAN WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: N/A, NO DEFECTS WERE CONFIRMED.

    Additional Manufacturer Narrative · 1

    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 FOREIGN MATTER WAS FOUND IN A BD SYRINGE 10ML LUER-LOK¿ TIP SYRINGE BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733722 BD SYRINGE 10ML LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7212573 00382903029952

    Patients

    Seq Age Sex Outcome Treatment
    1 Other