BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCANTO IVD

    MDR report key: 10662132 · Received October 12, 2020

    Report

    Report Number
    2916837-2020-00177
    Event Type
    Malfunction
    Date Received
    October 12, 2020
    Date of Event
    September 21, 2020
    Report Date
    December 21, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, AND RISK ANALYSIS, THE ROOT CAUSE OF THE WASTE LEAKAGE NOT CONTAINED WITHIN THE FACSCANTO WET CART WAS DUE TO A WORN WASTE CONNECTOR ON THE PANEL, PART #59-10181-05 - CPLN BDY PNL MT 1/8ID ORG. THIS ISSUE WAS CONFIRMED BY TWO FSE¿S (FIELD SERVICE ENGINEER) WHICH REPLACED THE CONNECTOR. AFTER THE REPAIR THE INSTRUMENT WAS FUNCTIONING NORMALLY WITH NO FURTHER LEAKAGE. THE PART WAS FROM NON-INVENTORIED STOCK AND WAS DISCARDED. NO RETURN SAMPLE FOR THESE PARTS WERE REQUESTED FOR EVALUATION BECAUSE IT IS NOT A RETURNABLE PART.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WASTE LINE IS LEAKING OUTSIDE OF INSTRUMENT WITH A BD FACSCANTO¿ IVD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WET CART IS LEAKING. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? NO. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. LEAK (IF YES EXPLAIN)? YES. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? WASTE FLUID. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO. ADDITIONALLY, ON 2020-9-21 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE WASTE FLUID WAS NOT UNDER PRESSURE (JUST A SLOW DRIP). THE WASTE WAS NOT MIXED WITH BLEACH YET, THE LEAK WAS LOCATED BEFORE THE WASTE ENTERED THE WASTE CONTAINER.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WASTE LINE IS LEAKING OUTSIDE OF INSTRUMENT WITH A BD FACSCANTO¿ IVD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WET CART IS LEAKING. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? NO. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. LEAK (IF YES EXPLAIN)? YES. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? WASTE FLUID. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO. ADDITIONALLY, ON 2020-9-21 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE WASTE FLUID WAS NOT UNDER PRESSURE (JUST A SLOW DRIP) THE WASTE WAS NOT MIXED WITH BLEACH YET, THE LEAK WAS LOCATED BEFORE THE WASTE ENTERED THE WASTE CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131783 BD FACSCANTO IVD NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other