BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DURASAFE¿ TRAY

    MDR report key: 17831122 · Received September 28, 2023

    Report

    Report Number
    3014704491-2023-00604
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    August 29, 2023
    Report Date
    December 7, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    CAZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1. NO DEFECTIVE SAMPLE WERE RETURNED, AND NO DEFECTIVE PHOTO WERE RETURNED FROM THE CUSTOMER, ROOT CAUSE CANNOT BE CONFIRMED. 2. REVIEW BATCH RECORD INFORMATION: 1) THE COMPLAINT BATCH NUMBER LOT#2347356 IS PACKAGED IN AS PACKAGING LINE, THE PRODUCTION DATE IS 2023-01, AND THE BATCH QUANTITY IS (B)(4). 2) CHECK THE IN-PROCESS INSPECTION AND SHIPMENT INSPECTION REPORT OF THIS BATCH OF PRODUCTS. THE TEST RESULTS MEET THE PRODUCT STANDARDS AND THERE IS NO ABNORMALITY. 3) CHECK THE PRODUCTION RECORDS AND MACHINE MAINTENANCE OF THIS BATCH OF PRODUCTS, AND THERE ARE NO ABNORMALITIES, DEVIATIONS OR REWORK ACTIVITIES. 3. DUE TO CUSTOMER DID NOT SPECIFY THE DETAIL NEEDLE WAS CLOGGED, PLANT CANNOT CONFIRM WHICH NEEDLE IS DEFECTED. SO, PLANT TESTED ALL THE NEEDLE OF RETAINED SAMPLE: SPINAL NEEDLE, EPIDURAL NEEDLE, PUNCTURE NEEDLES, ALL THE TEST RESULT ARE PASS, NO ABNORMALITY WAS OBSERVED, NO CLOGGED, AND NO FM WAS OBSERVED,ATTACHMENT1 -THE NEEDLE OF RETAINED SAMPLE, ATTACHMENT2- THE TEST OF RETAINED SAMPLE. 4. DUE TO NO DEFECTIVE SAMPLE WAS RETURNED, THE DEFECT MODE CANNOT BE IDENTIFIED, THE ROOT CAUSE CANNOT BE CONFIRMED. 5. THE PLANT CONTINUE PAY ATTENTION TO THIS DEFECT.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2347356. D.4. MEDICAL DEVICE EXPIRATION DATE: 06-JAN-2028. H.4. DEVICE MANUFACTURE DATE: 13-DEC-2022. D.4. MEDICAL DEVICE LOT #: 3003861. D.4. MEDICAL DEVICE EXPIRATION DATE: 13-FEB-2028. H.4. DEVICE MANUFACTURE DATE: 03-JAN-2023. 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

    FOR THE SACKS WITH BATCH NUMBER 3003861,3003869,2347356, ACCORDING TO THE FEEDBACK OF [(B)(6) HOSPITAL, DURING THE USE PROCESS: THE NEEDLES OF THE SACKS WERE FOUND TO BE BLOCKED AND THERE WERE FOREIGN BODIES, WHICH COULD NOT BE USED. THE CUSTOMER EXPECTS TO RECEIVE SAMPLES WITH 1:1 COMPENSATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD DURASAFE¿ TRAY EACH FROM LOTS 2347356 AND 3003861 HAD BLOCKED NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "FOR THE SACKS WITH BATCH NUMBER 3003861,3003869,2347356, ACCORDING TO THE FEEDBACK OF XXXXX, DURING THE USE PROCESS: THE NEEDLES OF THE SACKS WERE FOUND TO BE BLOCKED AND THERE WERE FOREIGN BODIES, WHICH COULD NOT BE USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003771 BD DURASAFE¿ TRAY ANESTHESIA CONDUCTION KIT CAZ BD (SUZHOU) 3003861

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown