BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL W/NDL 21X1 RB

    MDR report key: 9539903 · Received January 2, 2020

    Report

    Report Number
    1213809-2019-01326
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 18, 2019
    Report Date
    January 30, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096429
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY FIVE PHOTOS AND TWO BOXES, CONTAINING TWO PLASTIC BAGS OF SAMPLES, WERE RECEIVED. THE RETURNED SAMPLES WERE A MIX OF SEALED AND OPENED INDIVIDUALLY PACKAGED 10ML SYRINGES WITH NEEDLE FROM MULTIPLE BATCHES. THE SAMPLES WERE VISUALLY EVALUATED. 3 SYRINGES FROM BATCH #9015764 (P/N 309642). 2 SYRINGES FROM BATCH #5012595 (P/N 309642). 115 SYRINGES FROM BATCH #9015762 (P/N 309642). ALL OF THE ABOVE SYRINGES WERE OBSERVED TO HAVE A SMALL AMOUNT OF SILICONE PRESENT ON THE STOPPER AND/OR ROOF OF THE BARREL IN THE FLUID PATH. THE AMOUNT OF SILICONE OBSERVED WAS NORMAL AND EXPECTED AMOUNT FOR THIS PRODUCT PER PRODUCT SPECIFICATION. SMALL VARIATION BETWEEN INDIVIDUAL SAMPLES WAS OBSERVED WITH SOME EXHIBITING MORE VISIBILITY AND SOME LESS VISIBILITY. HOWEVER, ALL WERE WITHIN SPECIFICATION. TWO SYRINGES FROM BATCH 9015762 ARRIVED IN OPENED PACKAGES AND WERE OBSERVED TO HAVE WHITE HAIR-LIKE FIBERS AKIN TO ANIMAL HAIRS ON THE OUTSIDE OF THE BARRELS. ONE OF THESE SYRINGES ALSO HAD A FIBER INSIDE THE BARREL ON THE TOPPER IN THE FLUID PATH. DUE TO SAMPLES HAVING BEEN OPENED THE FOREIGN MATTER COULD NOT BE CONFIRMED TO HAVE ORIGINATED DURING THE MANUFACTURING PROCESS. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A "JELLY/SYRUPY" SUBSTANCE WAS FOUND INSIDE THE EMPTY SYRINGE 10ML LL W/NDL 21X1 RB, BUT THE PLUNGER DID "NOT FEEL STICKY" WHEN REMOVED. LOT# 9015762 HAD 1 OCCURRENCE OF THE EVENT, WHILE LOT# 9015764 HAD AN UNSPECIFIED NUMBER OF OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE EMPTY SYRINGE HAS A JELLY/SYRUPY SUBSTANCE INSIDE. THE PLUNGER DOES NOT FEEL STICKY WHEN THE PLUNGER IS REMOVED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9015762, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2019-01-15, MEDICAL DEVICE LOT #: 9015764, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2019-01-15. 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 A "JELLY/SYRUPY" SUBSTANCE WAS FOUND INSIDE THE EMPTY SYRINGE 10ML LL W/NDL 21X1 RB, BUT THE PLUNGER DID "NOT FEEL STICKY" WHEN REMOVED. LOT# 9015762 HAD 1 OCCURRENCE OF THE EVENT, WHILE LOT# 9015764 HAD AN UNSPECIFIED NUMBER OF OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE EMPTY SYRINGE HAS A JELLY/SYRUPY SUBSTANCE INSIDE. THE PLUNGER DOES NOT FEEL STICKY WHEN THE PLUNGER IS REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4859 SYRINGE 10ML LL W/NDL 21X1 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309642 SEE SECTION H.10. 30382903096429

    Patients

    Seq Age Sex Outcome Treatment
    1 Other