BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE, 1 ML

    MDR report key: 13261258 · Received January 14, 2022

    Report

    Report Number
    1213809-2021-00868
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 21, 2021
    Report Date
    February 5, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1083799. MEDICAL DEVICE EXPIRATION DATE: 2026-02-28. DEVICE MANUFACTURE DATE: 2021-03-24. MEDICAL DEVICE LOT #: 1127514. MEDICAL DEVICE EXPIRATION DATE: 2026-04-30. DEVICE MANUFACTURE DATE: 2021-05-07. MEDICAL DEVICE LOT #: 1146696. MEDICAL DEVICE EXPIRATION DATE: 2026-05-31. DEVICE MANUFACTURE DATE: 2021-05-26.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SEVENTY-EIGHT LOOSE 1ML LUER-LOCK SYRINGES (P/N 309648) WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. FOUR WERE FOUND TO BE MISSING THE PLUNGER COMPONENTS. TWO WERE SEVERELY DAMAGED AND MANGLED. EXCESSIVE SILICONE WAS FOUND ON FIVE SAMPLES. ILLEGIBLE SCALE MARKINGS WERE NOTED ON TWO SAMPLES. SIXTY-THREE SAMPLES WERE FOUND TO HAVE EMBEDDED FOREIGN MATTER THAT APPEARED TO BE DEGRADED PLASTIC FROM THE MOLDING PROCESS. SIX SAMPLES WERE ACCEPTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. POTENTIAL ROOT CAUSES FOR THE DAMAGED SYRINGE AND MISSING COMPONENTS ARE ASSOCIATED WITH THE ASSEMBLY PROCESS. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECTS IS ASSOCIATED WITH THE MARKING PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCHES #0059908, #1083799, #1127514, AND #1146696 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS FOR THE NOTED DEFECTS. THE EXCESSIVE SILICONE DEFECT IS A KNOWN ISSUE FOR BATCH #1127514. 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. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS 0059908, 1127514, 1146696 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. PRINT DEFECTS WERE NOTED DURING MANUFACTURE OF BATCH 1083799 . H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD LUER-LOK SYRINGE, 1 ML WERE DAMAGED BUT STILL OPERABLE, 4 HAD SCALE MARKING ISSUES, AND 2 HAD LOOSE PLUNGERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "2 DEFORMED, 4 INCOMPLETE SCALE, 2 LOOSE PLUNGERS ".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD LUER-LOK SYRINGE, 1 ML WERE DAMAGED BUT STILL OPERABLE, 4 HAD SCALE MARKING ISSUES, AND 2 HAD LOOSE PLUNGERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "2 DEFORMED, 4 INCOMPLETE SCALE, 2 LOOSE PLUNGERS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961405 BD LUER-LOK SYRINGE, 1 ML PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown