BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL SP125

    MDR report key: 11565811 · Received March 24, 2021

    Report

    Report Number
    1213809-2021-00160
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    February 25, 2021
    Report Date
    March 19, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096466
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NINE 5ML SYRINGES WERE RECEIVED AND EVALUATED. SIX WERE IN FULLY SEALED BLISTER PACKS FROM BATCH 8197840 (P/N 309646) AND THREE WERE LOOSE. THERE WERE ALSO THREE OPENED AND EMPTY BLISTER PACKS FROM THE SAME BATCH AND PART NUMBER. 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. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER WITH LOT #8092506 REGARDING ITEM #309646. 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: 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. ROOT CAUSE DESCRIPTION: IT APPEARED THE "GREASE-LIKE" SUBSTANCE WAS SILICONE, AND THE NORMAL AND EXPECTED AMOUNT WAS OBSERVED PER PRODUCT SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 5ML LL SP125 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309646 BATCH NO: UNKNOWN (8092846C06, 8092506C06) PROVIDED. IT WAS REPORTED THAT A GREASE-LIKE SUBSTANCE FOUND BETWEEN PISTON AND SYRINGE IN SEVERAL PACKAGES. VERBATIM: ANY INJURIES AND/OR HARM?: NOT SURE. WE HAVE BEEN USING THIS FOR INJECTION TO ANIMALS AND REAGENT PREPARATION. WHAT IS THE ISSUE YOU EXPERIENCED?: GREASE-LIKE SUBSTANCE FOUND BETWEEN PISTON AND SYRINGE IN SEVERAL PACKAGES. I AM AFRAID THIS CAUSES ANY CONTAMINATION AND/OR HARM. WOULD BE GREAT IF YOU CAN REPLACE THESE. I AM ALSO CURIOUS WHETHER THERE ARE SIMILAR ABNORMALITIES ON OTHER VOLUME SYRINGES IN OUR LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461527 SYRINGE 5ML LL SP125 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 00382903096466

    Patients

    Seq Age Sex Outcome Treatment
    1