BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 19335699 · Received May 16, 2024

    Report

    Report Number
    9610847-2024-00129
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    April 15, 2024
    Report Date
    August 19, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097037
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. BATCH# 3118868 #3118863 #3241014 B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 6 SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF DRUG POTENCY ISSUE WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT NO DAMAGE OR OTHER CONDITIONS WERE OBSERVED. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE SAMPLE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK HAD DRUG POTENCY ISSUE IT WAS REPORTED BY CUSTOMER THAT WE HAVE SEEN IRREGULAR PH SHIFTS IN OUR EPHEDRINE SULFATE/NS PRODUCT WHEN USING YOUR 5 ML SYRINGE VERBATIM SPECIFICALLY, WE HAVE SEEN IRREGULAR PH SHIFTS IN OUR EPHEDRINE SULFATE/NS PRODUCT WHEN USING YOUR 5 ML SYRINGE PACKAGED IN A 25-UNIT CONVENIENCE PACK. WE KNOW THIS PRODUCT TO BE VERY SENSITIVE TO PH SHIFT. RECENTLY, WE HAD TWO BATCHES OF PRODUCT FAIL FOR PH TESTING AND UPON EXPANDED TESTING, WE MEASURED AN OVERALL FAILURE RATE OF 16%. IN OTHER WORDS, MOST FILLED SYRINGES HAVE A PH THAT IS WITHIN THE EXPECTED RANGE, WITH SOME SMALL AMOUNT OF VARIABILITY. HOWEVER, 16% OF THOSE SYRINGES WILL HAVE PH FAILURES OUTSIDE OF OUR ACCEPTANCE RANGE. WE HAVEN¿T SEEN THIS ISSUE OVER SEVERAL YEARS MAKING THE PRODUCT, AND THE FAILURE RATE IS TOO HIGH FOR US TO HAVE NOT DETECTED IT OVER THIS PERIOD. WE HAVE DONE AN INTERNAL INVESTIGATION AND RULED OUT OUR MANUFACTURING PROCESS/COMPONENTS AS THE CAUSE. THEREFORE, I¿M WONDERING IF BD HAS MADE ANY RECENT CHANGES TO THEIR MANUFACTURING PROCESS OF THE 5 ML SYRINGE, OR IF THERE IS SOME NORMAL MANUFACTURING VARIATION THAT COULD EXPLAIN THIS. FOR EXAMPLE, VARYING AMOUNTS OF SILICONE LUBRICANT COULD BE THE CAUSE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401340 BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3241014 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown