BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 17863251 · Received October 3, 2023

    Report

    Report Number
    3003916417-2023-00296
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 19, 2023
    Report Date
    November 10, 2023
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. 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

    ADDITIONAL INFORMATION RECEIVED IT IS REPORTED THAT A QUALITY PROBLEM WAS DETECTED IN CODE 300017, SINCE ¿IT PRESENTS FAILURES AT THE TIME OF EXTRACTION AND APPLICATION OF THE MEDICATION; THEY ARE COVERED. THE PROCEDURE IS DELAYED AND THE NEEDLE HAS TO BE CHANGED TO CONTINUE. DUE TO THE NUMBER OF NEEDLES THAT WERE DAMAGED IN THE LAST MONTH, THE CUSTOMER DECIDES TO RETURN THE STOCK HE HAS FROM THAT BATCH FOR FEAR THAT THEY WILL BE CLOGGED. ¿THIS CUSTOMER HAD ALREADY REPORTED 13 PIECES FROM THE SAME LOT WITH THE SAME FAILURE (QP-061-23)¿ PASSWORD: 300017 DESCRIPTION: NEEDLE PRECISION GLIDE 40 MM 12 DMM SUPPLIER LOT: 2272818 QUANTITY RECEIVED: (B)(4) PIECES INVOICE: 9014437310 F. RECEPTION: 09.AUG.23 DEFECTIVE QUANTITY: (B)(4) PIECES. IN THE MONTH OF AUGUST, 3 SIMILAR CASES HAVE BEEN REPORTED IN THE SAME GDL BRANCH AND ONE REPORT IN THE BRANCH TIJ, THE TRACKING CODES ARE AS FOLLOWS: SUPPLIER CODE ((B)(4) LOT: 2272816 INTERNAL CODE P*******: QP-060-23 SUPPLIER CODE ((B)(4) LOT: 2272818 INTERNAL CODE *******: QP-061-23 SUPPLIER CODE (B)(4) LOT: 2272818 INTERNAL CODE *******: QP-065-23 SUPPLIER CODE (B)(4) LOT: 2272816 INTERNAL CODE *******: QP-066-23 THE FOLLOW-UP WILL BE GIVEN WITH THE COMPLAINT CODE QP-073-23. ********************** ON 27.SEP.2023, THROUGH SURVEY NPS # 72291095 RESPONSE, CUSTOMER PROVIDES THE FOLLOWING: ¿ DO THE (B)(4) PARTS REPORTED AS DEFECTIVE HAVE THE DEVIATION INDICATED IN THE EVENT DESCRIPTION? R: THE QUANTITY AFFECTED IS UNKNOWN. THE CUSTOMER REPORTS THE ISSUE, BUT WE DON'T DO THE MATH OF THE AMOUNT DEFECTIVE. ¿ HAS THERE BEEN ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? (DETAIL) R: FORTUNATELY, THERE WERE NO IMPACTS TO PATIENTS/HEALTHCARE PROFESSIONALS. ¿ WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT OCCURRED (IMAGING EXAMINATIONS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) N/A ¿ COULD YOU SEND PHOTOS OF THE SAMPLE? R: THERE ARE NO EVIDENCES, BUT THE FACILITY'S REPORT ONLY. (ADDED ON 29.SEP.2023) ______ CUSTOMER PROVIDED TO US THE ADDITIONAL INFORMATION BELOW. ¿ DO THE 650 PARTS REPORTED AS DEFECTIVE HAVE THE DEVIATION INDICATED IN THE EVENT DESCRIPTION? THAT'S RIGHT, THEY HAVE THE SAME DEFECT ALREADY REPORTED. ¿ HAS THERE BEEN ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? (DETAIL) NO. THEY ARE ONLY AFFECTING NURSING HOURS AND PRODUCING A GREATER NUMBER OF NEEDLES USED DURING THE ADMINISTRATION OF MEDICATIONS. ¿ WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT OCCURRED (IMAGING EXAMINATIONS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) NO, THERE WAS NO NEED FOR MEDICAL INTERVENTION. ¿ IS THE SAMPLE RELATED TO THE INCIDENT AVAILABLE FOR ANALYSIS? NO, IT WAS DISPOSED OF PROPERLY IN THE SHARPS CONTAINER. ¿ COULD YOU SEND PHOTOS OF THE SAMPLE? THERE ARE NO PHOTOS OF THE SAMPLE.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE WAS CLOGGED. THE FOLLOWING WAS TRANSLATED FROM (B)(6) TO ENGLISH: THAT A QUALITY PROBLEM WAS DETECTED IN CODE 300017, SINCE ¿IT PRESENTS FAILURES AT THE TIME OF EXTRACTION AND APPLICATION OF THE MEDICATION;

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740964 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 2272818

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown