BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7215893 · Received January 24, 2018

    Report

    Report Number
    1213809-2018-00008
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Date of Event
    December 18, 2017
    Report Date
    March 27, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: THREE OPEN 10ML PACKAGED SYRINGES WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7212583 (P/N 302995). THE SAMPLE WAS VISUALLY EVALUATED. THE ¿GREASY SUBSTANCE¿ OBSERVED ON THE BLACK STOPPER IS SILICONE USED IN THE MANUFACTURING PROCESS. THE SILICONE OBSERVED WAS EXCESSIVE 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. DHR REVIEW FOR BATCH 7249930 (P/N 302995): MANUFACTURING DATE: 09/29/2017 TO 09/30/2017. BATCH QUANTITY WAS (B)(4). ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7249930 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7212583 (P/N 302995): MANUFACTURING DATE: TO 08/21/2017. BATCH QUANTITY WAS (B)(4). ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7212583 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. INVESTIGATION CONCLUSION: ROOT CAUSE UNDETERMINED.

    Additional Manufacturer Narrative · 1

    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 A BD SYRINGE LUER-LOK¿ TIP, FOREIGN MATTER WAS FOUND AS A GREASY SUBSTANCE WAS REPORTED AT THE TIP OF THE SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58363 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7249930 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other