BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE ONLY SLIP TIP, NON-STERILE, BULK

    MDR report key: 7541582 · Received May 24, 2018

    Report

    Report Number
    1213809-2018-00334
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Date of Event
    May 2, 2018
    Report Date
    August 14, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE COMPLAINT SAMPLES WERE REPORTEDLY DESTROYED AND NOT RECEIVED FOR EVALUATION. INSTEAD, FOUR FULL BULK NON STERILE BOXES OF ¿REPRESENTATIVE¿ 10ML PRODUCT WERE RECEIVED, CONFIRMED TO BE FROM THE SAME BATCH #8001730 (P/N 301030). THE 3,400 SYRINGES WERE INSPECTED FOR PRESENCE OF EXCESS SILICONE. NO EXCESS SILICONE WAS FOUND PER PRODUCT SPECIFICATION. HOWEVER, SOME VARIATION IN SILICONE PRESENCE WAS OBSERVED ON THE STOPPER OF THE SYRINGES WHICH MAY MAKE IT MORE VISIBLE IN SOME OF THE INDIVIDUAL SYRINGES. ALL SILICONE CONTENT OBSERVED WAS ACCEPTABLE. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. THIS IS THE 1ST RELATED COMPLAINT FOR THIS DEFECT ON THE PROVIDED LOT NUMBER 8001730. 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. 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. INVESTIGATION CONCLUSION: THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. UNABLE TO DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD¿ SYRINGE ONLY SLIP TIP, NON-STERILE, BULK THERE WAS AN ISSUE WITH FOREIGN MATTER. IT WAS STATED ¿DURING AN IN-COMING INSPECTION IT WAS FOUND THAT 53 OUT OF 315 SYRINGES HAVE EXCESSIVE SILICONE AT THE TIP AND AROUND THE SEAL OF THE SYRINGE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    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 WITH THE USE OF THE BD¿ SYRINGE ONLY SLIP TIP, NON-STERILE, BULK THERE WAS AN ISSUE WITH FOREIGN MATTER. IT WAS STATED ¿DURING AN IN-COMING INSPECTION IT WAS FOUND THAT 53 OUT OF 315 SYRINGES HAVE EXCESSIVE SILICONE AT THE TIP AND AROUND THE SEAL OF THE SYRINGE". THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384611 BD¿ SYRINGE ONLY SLIP TIP, NON-STERILE, BULK SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8001730

    Patients

    Seq Age Sex Outcome Treatment
    1 Other