BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD FACSDUET SAMPLE PREP

    MDR report key: 10136168 · Received June 9, 2020

    Report

    Report Number
    2916837-2020-00024
    Event Type
    Injury
    Date Received
    June 9, 2020
    Date of Event
    February 13, 2020
    Report Date
    July 23, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    JQW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART 662588 FACSDUET AND S/N: (B)(6). PROBLEM STATEMENT: FSE CAUGHT HIS HAND ON THE PROBE WHILE PERFORMING A SCHEDULED PM SERVICE ON THE FACSDUET ON 13FEB2020. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 13FEB2019 TO DATE 13FEB2020 (ROLLING 12 MONTHS). RELATED QN(S) NUMBER: (B)(4). COMPLAINT TREND: THIS IS THE ONLY COMPLAINT RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 13FEB2019 TO DATE 13FEB2020 (ROLLING 12 MONTHS). MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF DHR FOR PN662588 SERIAL NUMBER: (B)(6) WAS REVIEWED. DATE OF MANUFACTURE: 24MAY2019. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW THE FSE DID NOT FOLLOW ESTABLISHED SAFETY INSTRUCTIONS PER BD FACSDUET SERVICE MANUAL DOC. NO 10000423011 REV 01 (CHAPTER 1, PG 7) PRIOR TO PERFORMING THE PM SERVICE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4). INSTALL DATE: 12SEP2019. DEFECTIVE PART NUMBER: NO PARTS WERE REPLACED DURING THE PM. WORK ORDER NOTES: SUBJECT / REPORTED: THIS WAS A SCHEDULED PM SERVICE, PROBLEM DESCRIPTION: N/A, CAUSE: FSE FAILED TO FOLLOW ESTABLISHED SAFETY INSTRUCTIONS PER BD FACSDUET SERVICE MANUAL DOC. NO 10000423011 REV 01 (CHAPTER 1, PG 7), WORK PERFORMED: SCHEDULED PM, SOLUTION: N/A. RETURNED SAMPLE EVALUATION: NO REQUEST WAS MADE BECAUSE THERE WERE NO DEFECTIVE PARTS. RISK ANALYSIS: RISK MANAGEMENT FILE PART #10000225098, REVISION VER H WAS REVIEWED. HAZARD(S) IDENTIFIED? YES, NO. IF NO (TO ABOVE), WHAT ACTIONS WILL BE TAKEN? HAZARD ID : 1.4.12. HAZARD: OPERATOR GETS CUT DUE TO LACERATION (EXPOSURE TO SHARP EDGES). SEVERITY: 3. PROBABILITY: 1. RISK INDEX: 3. IMPLEMENTATION: NEMKO SAFETY TEST IEC61010-01 RISK CONTROL: THE SYSTEM IS DESIGNED TO ISOLATE AND PROTECT THE USER FROM SAFETY HAZARDS WHEN ACCESS POINTS ARE OPEN. NEW HAZARD: MITIGATION(S) SUFFICIENT: YES, NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT, THE ROOT CAUSE WAS DETERMINED TO BE FSE FAILED TO FOLLOW ESTABLISHED SAFETY INSTRUCTIONS PER BD FACSDUET SERVICE MANUAL DOC. NO 10000423011 REV 01 (CHAPTER 1, PG 7). CONCLUSION: BASED ON THE INVESTIGATION RESULTS, COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A NEEDLESTICK INJURY DURING USE WITH A BD FACSDUET¿ SAMPLE PREP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE STICK INJURY. AT THE TIME OF THE EVENT FSE WAS WORKING IN CLOSE PROXIMITY TO THE PROBE, WHICH HADN'T BEEN MOVED SUFFICIENTLY FAR AWAY. FSE BRIEFLY CAUGHT HIS HAND ON THE PROBE AS HE WORKED NEAR BY.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A NEEDLESTICK INJURY DURING USE WITH A BD FACSDUET¿ SAMPLE PREP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE STICK INJURY. AT THE TIME OF THE EVENT FSE WAS WORKING IN CLOSE PROXIMITY TO THE PROBE, WHICH HADN'T BEEN MOVED SUFFICIENTLY FAR AWAY. FSE BRIEFLY CAUGHT HIS HAND ON THE PROBE AS HE WORKED NEAR BY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595603 BD FACSDUET SAMPLE PREP NA JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention