BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 8203067 · Received December 28, 2018

    Report

    Report Number
    1213809-2018-00943
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 12, 2018
    Report Date
    April 4, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903009122
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO SEALED AND ONE OPENED 10ML SYRINGE BLISTER PACKAGES WERE RECEIVED AND CONFIRMED TO BE FROM BATCH # 8123909 (P/N 300912). ONE SYRINGE IN AN OPEN BLISTER PACKAGE WAS RECEIVED FROM BATCH #8213972 (P/N 300912). ALL OF THE SAMPLES WERE VISUALLY INSPECTED. THE STOPPERS AND BARREL ROOFS OF ALL 4 SYRINGES WERE OBSERVED TO HAVE A SMALL AMOUNT OF SILICONE PRESENCE. THE OBSERVED AMOUNT OF SILICONE WAS NORMAL AND EXPECTED AMOUNT FOR THIS PRODUCT PER PRODUCT SPECIFICATION. NO DEFECTS WERE OBSERVED. 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. 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 NOT DEFINED SINCE DEFECTS WERE NOT CONFIRMED IN SAMPLES RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD SYRINGE LUER-LOK¿ TIP THERE WAS AN ISSUE WITH OILY FILM IN THE INTERIOR OF THE SYRINGE.

    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 #: 8123909, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2018-05-03. MEDICAL DEVICE LOT #: 8213972, MEDICAL DEVICE EXPIRATION DATE: 2023-07-31, DEVICE MANUFACTURE DATE: 2018-08-01. (B)(6). 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 OILY FILM IN THE INTERIOR OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044098 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903009122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other