BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS BL 22GAX1.00IN QSYTE-CAPY NONPVC

    MDR report key: 19448748 · Received June 3, 2024

    Report

    Report Number
    3002601200-2024-00225
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    February 20, 2023
    Report Date
    June 12, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    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

    1. DHR/BHR REVIEW 1. THE BATCH NUMBER OF THE COMPLAINED PRODUCT IS 3234096, IS 22G AND PRODUCT CODE IS383738, PRODUCED ON 2023/09, WITH A TOTAL OF (B)(4) PIECES IN THIS BATCH; 2. INSPECTION PROCESS INSPECTION AND DELIVERY INSPECTION REPORT, THE TEST RESULTS MEET THE PRODUCT STANDARDS, NO ABNORMALITY; 3. CHECK THE PRODUCTION RECORDS FOR THIS BATCH OF PRODUCTS THAT THERE ARE NO NONCONFORMITIES, DEVIATIONS OR REWORK ACTIVITIES IN THE PROCESS OF THIS BATCH OF PRODUCTS; 2. TAKE THE RETAINED SAMPLE OF THIS BATCH FOR NEEDLE PENETRATION FORCE TEST,CATHETER TIP PENETRATION FORCE TEST,CATHETER DRAG FORCE TEST AND LIE DISTANCE TEST, NO FOUND ABNORMAL, REFER TO ATTACHMENT 1. 3.THE CUSTOMER DID NOT RETURN ANY SAMPLES OR PHOTOS, CANNOT CONFIRM THE SPECIFIC DEFECT STATUS; 4.THE HISTORY OF CUSTOMER COMPLAINTS FOR THE SAME BATCH OF PRODUCTS HAS BEEN REVIEWED, AND NO COMPLAINTS OF THE SAME DEFECTS HAVE BEEN FOUND. IN SUMMARY, DUE TO CUSTOMER DID NOT RETURN ANY SAMPLES, THE SPECIFIC DEFECT STATUS CANNOT BE CONFIRMED, AND THE ROOT CAUSE OF THE COMPLAINT CANNOT BE CONFIRMED. THE PLANT WILL CONTINUE TO PAY ATTENTION TO AND MONITOR THE TREND OF THE DEFECT COMPLAINT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS BL 22GAX1.00IN QSYTE-CAPY NONPVC CATHETER BROKE / SEPARATED BEFORE PLACEMENT. THIS PATIENT WAS ADMITTED TO THE HOSPITAL TODAY AS AN EMERGENCY FOR AN ECTOPIC PREGNANCY AND WAS GIVEN AN IV NEEDLE TO REHYDRATE THE PATIENT AS PRESCRIBED. THE NEEDLE WAS INSERTED AT THE PROPER ANGLE DURING PUNCTURE, BUT THE CLEAR CANNULA WAS BROKEN AND TWISTED DURING THE PUSHING OF THE CLEAR CANNULA NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610421 BD PEGASUS BL 22GAX1.00IN QSYTE-CAPY NONPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3234096

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown