BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LS SP125

    MDR report key: 12145920 · Received July 9, 2021

    Report

    Report Number
    1213809-2021-00485
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 11, 2021
    Report Date
    June 25, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096474
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: TWO HUNDRED AND SEVENTY-THREE 5ML SYRINGES (MATERIAL 309647) IN THEIR SEALED BLISTERPAKS WERE RECEIVED. TWO HUNDRED AND SIXTY-ONE WERE FROM BATCH 1019410, EIGHT WERE FROM BATCH 1019409, AND ONE EACH FROM BATCHES 1102727, 9115907, 0170636, AND 9336432. THE SAMPLES WERE VISUALLY EVALUATED. THIRTEEN SAMPLES FROM BATCH 1019410 WERE FOUND TO HAVE EXCESSIVE SILICONE PRESENT. THE NORMAL ACCEPTABLE AMOUNT OF SILICONE WAS PRESENT IN SAMPLES RECEIVED FROM THE OTHER LISTED BATCHES. 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. POTENTIAL ROOT CAUSE FOR THE EXCESSIVE SILICONE DEFECT FROM BATCH 1019410 IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE EXCESS SILICONE IS LIKELY RELATED TO THE SILICONE GUN MALFUNCTION WHICH WAS DETECTED AND CORRECTED DURING THE MANUFACTURING PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH 1019410 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED FOR BATCHES 1019409, 1102727, 9115907, 0170636, AND 9336432. POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY . FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THESE BATCHES 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. INVESTIGATION CONCLUSION: THE AQL FOR EXCESS LUBRICANT IS 1.0%. (B)(4). THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH #1019410 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 300 SYRINGE 5ML LS SP125 EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE DISCOVERED A STICKY SUBSTANCE INSIDE OF MULTIPLE SYRINGES INSIDE THE SEALED PACKAGING. WE AUDITED ALL SEALED CASES WITH THIS LOT NUMBER AND FOUND IMPACTED PRODUCT IN THREE DIFFERENT CASES. WHEN AUDITING A DIFFERENT LOT NUMBER, WE DID NOT IDENTIFY THE SAME ISSUE. QTY IMPACTED  300 EA. PHYSICAL CONFIRMATION OF 10 DIFFERENT SYRINGES (ALL 300 ARE SEQUESTERED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043702 SYRINGE 5ML LS SP125 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309647 1019410 30382903096474

    Patients

    Seq Age Sex Outcome Treatment
    1