BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE ENTERAL 10ML BNS

    MDR report key: 10049252 · Received May 12, 2020

    Report

    Report Number
    1213809-2020-00304
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 22, 2020
    Report Date
    June 19, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-06-01. H.6. INVESTIGATION SUMMARY : NINE SEALED PACKAGED 10ML ENTERAL/ORAL SYRINGES WERE RECEIVED. THE PACKAGES WERE CHS MED-RX LABELED PRODUCT NOT PRODUCED BY BD. THE 10ML SYRINGES HAD TIP CAPS ATTACHED. THE PACKAGES WERE ALL LABELED WITH DIFFERENT CHS LOT NUMBERS. THE SYRINGES WERE VISUALLY EVALUATED FOR THE REPORTED DEFECT. NO FOREIGN SUBSTANCE WAS FOUND IN THE FLUID PATH ON THE STOPPER NOR IN THE TIP. THE ONLY SUBSTANCE OBSERVED WAS SMALL AMOUNT OF MEDICAL GRADE SILICONE. THE AMOUNT OBSERVED WAS NORMAL AND EXPECTED AMOUNT FOR THIS SIZE SYRINGES PER PRODUCT SPECIFICATION. NO PLASTIC MOLDING DEFECTS WERE FOUND. NO DEFECTS WERE CONFIRMED IN THE SAMPLES RECEIVED. 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. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 249 SYRINGES ENTERAL 10ML BNS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305858 BATCH NO.:8120914, 8283661, 8283662, 8303979, 9042682, 9066794, 9095665. PER EMAIL: PLEASE BE ADVISED THAT ONE OF OUR GOOD CUSTOMER'S HAS LOGGED TWO COMPLAINT WITH RESPECT TO THE 10 ML ENTERAL SYRINGE COMPONENTS AND DETAILS ARE AS FOLLOWS: O QTY. MULTIPLE UNITS EXHIBITED THROUGHOUT ALL LOTS O DEFECT: ALL SYRINGES EXHIBITING A GREASY (YELLOW) RESIDUE TRAPPED BETWEEN THE END OF THE RUBBER PLUNGER AND THE TIP OF THE SYRINGE. OUR CUSTOMER IS EXTREMELY CONCERNED ABOUT THE SAFETY OF THESE SYRINGES AND WHETHER OR NOT THE ARE ACCEPTABLE FOR USE OR CONTAMINATED PRODUCT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8120914. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2018-04-30. MEDICAL DEVICE LOT #: 8283661. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-10-10. MEDICAL DEVICE LOT #: 8283662. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-10-10. MEDICAL DEVICE LOT #: 8303979. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31. DEVICE MANUFACTURE DATE: 2018-10-30. MEDICAL DEVICE LOT #: 9042682. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2019-02-11. MEDICAL DEVICE LOT #: 9066794. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-03-07. MEDICAL DEVICE LOT #: 9095665. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-04-05.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 249 SYRINGES ENTERAL 10ML BNS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305858, BATCH NO.:8120914, 8283661, 8283662, 8303979, 9042682, 9066794, 9095665. PER EMAIL: PLEASE BE ADVISED THAT ONE OF OUR GOOD CUSTOMER'S HAS LOGGED TWO COMPLAINT WITH RESPECT TO THE 10 ML ENTERAL SYRINGE COMPONENTS AND DETAILS ARE AS FOLLOWS: O QTY. MULTIPLE UNITS EXHIBITED THROUGHOUT ALL LOTS O DEFECT: ALL SYRINGES EXHIBITING A GREASY (YELLOW) RESIDUE TRAPPED BETWEEN THE END OF THE RUBBER PLUNGER AND THE TIP OF THE SYRINGE. OUR CUSTOMER IS EXTREMELY CONCERNED ABOUT THE SAFETY OF THESE SYRINGES AND WHETHER OR NOT THE ARE ACCEPTABLE FOR USE OR CONTAMINATED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509753 SYRINGE ENTERAL 10ML BNS SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other