BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTER

    MDR report key: 19576768 · Received June 20, 2024

    Report

    Report Number
    3002601200-2024-00266
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    May 10, 2024
    Report Date
    June 25, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. NO SAMPLE RETURNED, NO DEFECT PICTURE RETURNED 2. REVIEW BATCH RECORD INFORMATION, 1. THE COMPLAINT LOT 3171232 WAS PRODUCED IN THE PRN AUTOMATIC ASSEMBLY LINE, THE PRODUCTION DATE IS 2023-07, AND THE M860 PACKAGING MACHINE WAS PACKAGED IN 2023-07, AND THE BATCH OF PRODUCTS TOTALED 439.6K 2. CHECK THE 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. CHECK THE APPEARANCE OF THE RETAINED SAMPLE OF COMPLAINT LOT , NO ABNORMALITY WAS OBSERVED ON THE APPEARANCE OF RETAINED SAMPLE. 4. ROOT CAUSE 1 ACCORDING TO THE CUSTOMER DESCRIPTION, THE DEFECT IS THE SHRINK BAND EDGE ROUGH ,WHICH WAS OCCURRED THE SHRINK BAND CUTTING STATION , THE SURFACE OF BLADE IS NOT SMOOTHLY CAUSED. 2 IT'S A LOW PROBABILITY EVENT, INSPECT THE SHRINK BAND EDGE OF CURRENT PRODUCT, LOT- 4149627, QUANTITY (B)(6) K, NO OBSERVED THE ABNORMAL ON THE EDGE OF SHRINK BAND . 5. ACTION INFORM THE DEFECT ON THE SSU MEETING ,AND ASK THE OPERATOR INSPECT THE SHRINK BAND EDGE OF PRN, IF OBSERVE THE ROUGH EDGE OF SHRINK BAND OF PRN, NEED TO REJECT THE BAD PRODUCT, AND ASK TO THE TECHNICIAN TO CHANGE NEW BLADE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD PRN ADAPTER / CONNECTOR DEFECTIVE / DAMAGED. MAY 10, 2024 09:0012 A DISPOSABLE HEPARIN CAP WAS INSTALLED ON THE LEFT-HAND INDWELLING NEEDLE IN BED A29 AND PROPERLY FIXED. DURING THE WARD INSPECTION AT 18:00, THE PATIENT COMPLAINED OF PAIN AT THE FIXATION SITE OF THE INDWELLING NEEDLE. AFTER INSPECTION, IT WAS FOUND THAT THE PATIENT'S SKIN WAS DAMAGED AND WAS IN CONTACT WITH THE SKIN. THE PLASTIC EDGE OF THE DISPOSABLE HEPARIN CAP THAT CAME INTO CONTACT WAS ROUGH AND HAD BURRS, WHICH CAUSED SKIN DAMAGE TO THE PATIENT. THE DISPOSABLE HEPARIN CAP HAD TO BE REPLACED. THE INCIDENT CAUSED SERIOUS ADVERSE EFFECTS ON THE PATIENT. THE MEDICAL STAFF EXPLAINED THE REASONS AND COMMUNICATED WITH THE PATIENT. THE PATIENT ACCEPTED THE INCIDENT. THE PERSON WHO DISCOVERED THE INCIDENT REPORTED THE INCIDENT TO THE HEAD NURSE AND INFORMED THE MEDICAL ENGINEERING DEPARTMENT, WHO CONTACTED THE PERSON IN CHARGE OF PURCHASING. MANUFACTURER, PLEASE REPORT THE PROBLEM WITH THIS CONSUMABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655043 BD PRN ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BD SUZHOU (MDS) 3171232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown