BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD FACS SAMPLE PREP ASSISTANT III

    MDR report key: 12010557 · Received June 16, 2021

    Report

    Report Number
    2916837-2021-00279
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    May 27, 2021
    Report Date
    August 4, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    PER
    UDI-DI
    00382906472052
    PMA / PMN Number
    K131301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: FSE SPA NEEDLE INCIDENT. 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: THIS IS THE ONLY COMPLAINT 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 REPORT: THE BD FIELD SAFETY ENGINEER WAS AT THE CUSTOMER FOR A NON-EMERGENCY REPAIR OF THE BARCODE READER OF A BD FACS¿ SAMPLE PREP ASSISTANT III. DURING THE REPAIR THE FSE HAS SCRATCHED HIS LEFT HAND ON THE SPA NEEDLE. THE INSTRUMENT IS NORMALLY USED FOR HIV SAMPLES. UPON ARRIVAL THE NEEDLE WAS CLEANED AS PER NORMAL PROCEDURES. FSA WAS ABLE TO DISINFECT HIS HAND WITH SOAP AND DISINFECTANT IMMEDIATELY AFTER THE INCIDENT. FSE WILL CONTACT PERSONAL DOCTOR FOR CONSULTATION. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: NO WORK ORDER WAS INITIATED. INSTALL DATE: (B)(6) 2015. DEFECTIVE PART NUMBER: N/A. RETURNED SAMPLE EVALUATION: N/A. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: RISK MANAGEMENT FILE PART #100245RA, REVISION 02 WAS REVIEWED. HAZARD(S) IDENTIFIED? YES OR NO. HAZARD ID: 3.2.32. HAZARD: SERVICE HAZARDS. SEVERITY: 5. PROBABILITY: 1. RISK INDEX: 5. IMPLEMENTATION: BD FACS SPA SERVICE MANUAL PN333917 - BD FACS SAMPLE PREP USER¿S GUIDE 23-13406-03. RISK CONTROL: ALARP. MITIGATION(S) SUFFICIENT: YES OR NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT, AND THE SERVICE REPORT THE ROOT CAUSE WAS FAILURE TO FOLLOW SERVICE PROCEDURES CALLING FOR WORKING WITH THE SAFETY COVER UP. CONCLUSION: BASED ON THE INVESTIGATION RESULT, AND THE SERVICE REPORT THE FSE FAILED TO FOLLOW SERVICE PROCEDURES CALLING FOR WORKING WITH THE SAFETY COVER UP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FSE SCRATCHED HIS LEFT HAND ON THE NEEDLE OF THE BD FACS¿ SAMPLE PREP ASSISTANT III. UPON ARRIVAL NEEDLE WAS CLEANED PER PROCEDURE. SCRATCH WAS CLEANED AND DISINFECTED, FSE WILL CONTACT HIS PERSONAL DOCTOR FOR CONSULTATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BD FIELD SAFETY ENGINEER WAS AT THE CUSTOMER FOR A NON-EMERGENCY REPAIR OF THE BARCODE READER OF A BD FACS¿ SAMPLE PREP ASSISTANT III. DURING THE REPAIR THE FSE HAS SCRATCHED HIS LEFT HAND ON THE SPA NEEDLE. THE INSTRUMENT IS NORMALLY USED FOR HIV SAMPLES. UPON ARRIVAL THE NEEDLE WAS CLEANED AS PER NORMAL PROCEDURES. FSA WAS ABLE TO DISINFECT HIS HAND WITH SOAP AND DISINFECTANT IMMEDIATELY AFTER THE INCIDENT. FSE WILL CONTACT PERSONAL DOCTOR FOR CONSULTATION. FSE HAS SCRATCHED HIS LEFT HAND DURING A NON-EMERGENCY REPAIR OF THE BARCODE READER. INSTRUMENT IS NORMALLY USED FOR HIV SAMPLES. UPON ARRIVAL NEEDLE WAS CLEAN AS RESULT OF THE NORMAL CLEANING PROCEDURES OF THE INSTRUMENT ITSELF. THESE CLEANSINGS HAPPENED WITH AT LEAST 4TO5 TIMES A GOOD CLEAN TROUGH WITH DISTILLED WATER. LAST DECONTAMINATION WITH FACS CLEAN WAS ON (B)(6) 2021 ACCORDING TO THE INFORMATION. FSE WAS ABLE TO INSTANTLY AFTER THE INCIDENT DISINFECT THE COMPLETE HAND WITH SOAP AND DISINFECTANTS.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. 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 · 1

    IT WAS REPORTED THAT THE FSE SCRATCHED HIS LEFT HAND ON THE NEEDLE OF THE BD FACS¿ SAMPLE PREP ASSISTANT III. UPON ARRIVAL NEEDLE WAS CLEANED PER PROCEDURE. SCRATCH WAS CLEANED AND DISINFECTED, FSE WILL CONTACT HIS PERSONAL DOCTOR FOR CONSULTATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BD FIELD SAFETY ENGINEER WAS AT THE CUSTOMER FOR A NON-EMERGENCY REPAIR OF THE BARCODE READER OF A BD FACS¿ SAMPLE PREP ASSISTANT III. DURING THE REPAIR THE FSE HAS SCRATCHED HIS LEFT HAND ON THE SPA NEEDLE. THE INSTRUMENT IS NORMALLY USED FOR (B)(6) SAMPLES. UPON ARRIVAL THE NEEDLE WAS CLEANED AS PER NORMAL PROCEDURES. FSA WAS ABLE TO DISINFECT HIS HAND WITH SOAP AND DISINFECTANT IMMEDIATELY AFTER THE INCIDENT. FSE WILL CONTACT PERSONAL DOCTOR FOR CONSULTATION. FSE HAS SCRATCHED HIS LEFT HAND DURING A NON-EMERGENCY REPAIR OF THE BARCODE READER. INSTRUMENT IS NORMALLY USED FOR (B)(6) SAMPLES. UPON ARRIVAL NEEDLE WAS CLEAN AS RESULT OF THE NORMAL CLEANING PROCEDURES OF THE INSTRUMENT ITSELF. THESE CLEANINGS HAPPENED WITH AT LEAST 4TO5 TIMES A GOOD CLEAN TROUGH WITH DISTILLED WATER. LAST DECONTAMINATION WITH FACS CLEAN WAS ON 21/05/2021 ACCORDING TO THE INFORMATION. FSE WAS ABLE TO INSTANTLY AFTER THE INCIDENT DISINFECT THE COMPLETE HAND WITH SOAP AND DISINFECTANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907312 BD FACS SAMPLE PREP ASSISTANT III SEE H10 PER BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 647205 NA 00382906472052

    Patients

    Seq Age Sex Outcome Treatment
    1 Other