BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAMPLE PREP ASSISTANT (SPA)

    MDR report key: 12770803 · Received November 8, 2021

    Report

    Report Number
    2916837-2021-00431
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    October 12, 2021
    Report Date
    February 15, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 337170 SPAII AND SERIAL NUMBER: (B)(6) PROBLEM STATEMENT: CUSTOMER REPORTED: WASH STATION IS OVERFLOWING. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2020 TO DATE (B)(6) 2021 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 2 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2020 TO DATE (B)(6) 2021 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: PER FSE SERVICE CALL REPORT: 1. ASKED CUSTOMER TO CLEAN INLINE FILTER. 2. CUSTOMER CLEANED THE INLINE FILTER. SPA IS OPERATING WITH NO ISSUES. CUSTOMER CONFIRMED CASE IS CLOSED. SERVICE MAX REVIEW: REVIEW OF RELATED WORK INSTALL DATE: (B)(6) 2009 DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION IS OVERFLOWING. PROBLEM DESCRIPTION: FLUIDIC CLOGG. CAUSE: CLOGGED INLINE FILTER. WORK PERFORMED: CLEANED INLINE FILTER. SOLUTION: CLEANED INLINE FILTER. RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND PN337170 WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: RISK MANAGEMENT FILE PART # (B)(4), REVISION 02 WAS REVIEWED. HAZARD(S) IDENTIFIED? YES/ NO. HAZARD ID: 3.1.29 _ HAZARD: ENVIRONMENTAL BIOHAZARD SEVERITY: 5 PROBABILITY: 1 RISK INDEX: 5 IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE RISK CONTROL:_ALARP MITIGATION(S) SUFFICIENT YES/NO ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S CUSTOMER CALL REPORT THE ROOT CAUSE WAS CLOGGED INLINE FILTER CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S CUSTOMER CALL REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION OVERFLOW.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE RUNNING BD SAMPLE PREP ASSISTANT (SPA) THE WASH STATION LEAKED BIOHAZARDOUS WASTES OUTSIDE INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE WASH STATION OVERFLOWING AND IT LOOKS RED. 1) WAS THE LEAK LIQUID OR AIR? LIQUID. 2) WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3) WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO 4) WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 5) DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE . 6) WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? 7) WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE RUNNING BD SAMPLE PREP ASSISTANT (SPA) THE WASH STATION LEAKED BIOHAZARDOUS WASTES OUTSIDE INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE WASH STATION OVERFLOWING AND IT LOOKS RED. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667929 BD SAMPLE PREP ASSISTANT (SPA) STATION, PIPETTING AND DILUTING, FOR CLINICAL USE JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown