BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOTTLE,NF W/SAL

    MDR report key: 16443520 · Received February 27, 2023

    Report

    Report Number
    1219343-2023-00004
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    January 13, 2023
    Report Date
    February 24, 2023
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    KSR
    PMA / PMN Number
    BK020001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DURING THE MANUFACTURING PROCESS, A SLIT IS MADE TO THE SAMPLING PORT. THIS SLIT IS A PRE-CUT THAT GOES THROUGHOUT THE PORT, AND IS DESIGNED TO PERMIT THE PENETRATION OF THE SAMPLING CANNULA. CURRENT PROCESS CONTROLS INCLUDE: FUNCTIONAL TEST TO 10 RANDOM SAMPLES PER HOUR WITH A GO, NO-GO GAGE TO CONFIRM SLIT PRESENCE. FUNCTIONAL AQL SAMPLING TO PERFORM AN AUTOMATED PENETRATION TEST WITH A CANNULA. ROOT CAUSE ANALYSIS: THE MOST PROBABLE CAUSE IS THAT THE SLIT, ON THE AFFECTED UNITS, WAS NOT CENTERED. PENETRATING THE SAMPLING PORT THROUGH A SECTION WHERE THE SLIT IS NOT LOCATED IS NOT POSSIBLE, THE PORT WILL ELONGATE BUT WILL NOT PENETRATE THRU SEPTUM. THE ABOVE IS CONSISTENT WITH RETURNED COMPLAINT SAMPLES; THE SLIT WAS OBSERVED TO BE NOT CENTERED. NO SAMPLES HAVE BEEN OBSERVED WITHOUT A SLIT. THE BLADE THAT MAKES THE SLIT MIGHT SLIGHTLY MISALIGN OVERTIME DUE TO NORMAL WEAR AND TEAR OF THE MANUFACTURING PROCESS. CORRECTIVE ACTION PLAN: IN ORDER TO AVOID THE USAGE OF A MISALIGNED BLADE, THAT COULD RESULT IN A NOT CENTERED SLIT ON THE SAMPLING PORTS, A PREVENTIVE MAINTENANCE ROUTINE WAS IMPLEMENTED ON FEBRUARY 8, 2023 TO ESTABLISH A MONTHLY REQUIREMENT TO REPLACE THE BLADE.

    Description of Event or Problem · 0

    ON JANUARY 31, 2023, HAEMONETICS WAS MADE AWARE THAT A CUSTOMER EMPLOYEE SUSTAINED A SEVERE SPRAIN WHILE SAMPLING 0694S-00 PLASMA BOTTLES. THE EMPLOYEE COULD NOT SAY SPECIFICALLY HOW THE INJURY OCCURRED, HOWEVER HE INDICATED THERE WAS REPETITIVE MOTION FROM PUTTING THE CANNULA INTO THE MEMBRANE AND THIS PROCESS TAKING 3-4 MINUTES, STATING THE MEMBRANE WOULD STRETCH LIKE A RUBBER BAND' CAUSING THE EMPLOYEE TO CONTINUALLY PUSH INTO THE MEMBRANE TO GET THE SAMPLE DRAWN. NO SURGERY OR HOSPITALIZATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753153 BOTTLE,NF W/SAL BOTTLE,NF W/SAL KSR HAEMONETICS CORPORATION 0694S-00 2211030L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other