BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC

    MDR report key: 18744031 · Received February 20, 2024

    Report

    Report Number
    3002601200-2024-00045
    Event Type
    Injury
    Date Received
    February 20, 2024
    Date of Event
    January 17, 2024
    Report Date
    March 25, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    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 3093694, IS 20G AND PRODUCT CODE IS 383746, PRODUCED ON 2023/05, WITH A TOTAL OF (B)(4) PIECES IN THIS BATCH; (2) CHECK THE PROCESS INSPECTION AND DELIVERY INSPECTION REPORT. THE TEST RESULTS ALL MEET THE PRODUCT STANDARDS AND THERE ARE NO ABNORMALITIES; (3) CHECK THE PRODUCTION RECORDS, THERE WERE NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 2. NO SAMPLES OR PICTURES WERE RETURNED. 3. TEST THE CAP TORQUE OF THE RETAIN SAMPLE, THE TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 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. 5. PEGASUS PLUS PRODUCTS WITH STRAIGHT SPECIFICATIONS CAN WITHSTAND 300PSI PRESSURE, AND THE CONNECTOR NEED TO BE UNSCREWED DURING USE. SKU#: 383746 IS A Y-SHAPED SPECIFICATION OF PEGASUS PLUS PRODUCT, WHICH IS CLINICALLY USED FOR PERIPHERAL VENOUS INFUSION. THE HIGH-PRESSURE INJECTOR USED FOR THIS PRODUCT WILL CAUSE PRODUCT LEAKAGE OR DAMAGE, THE INSTRUCTIONS FOR USE WARN THIS. 6. FOR THE MARKET DEMAND, BD PLANT SPECIALLY MANUFACTURE PEGASUS PLUS DEVICES WITH STRAIGHT SPECIFICATIONS FOR POWER INJECTORS. THE CODE IS 383740, 383747, 383745. IN SUMMARY, NO ABNORMALITY IS FOUND ON PROCESS AND THE RETAINED SAMPLE. SKU#: 383746 IS A Y-SHAPED SPECIFICATION OF PEGASUS PLUS PRODUCT, WHICH IS CLINICALLY USED FOR PERIPHERAL VENOUS INFUSION. THE HIGH-PRESSURE INJECTOR USED FOR THIS PRODUCT WILL CAUSE PRODUCT LEAKAGE OR DAMAGE. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED TO BE RELATED TO PRODUCT QUALITY.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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 PNK 20GAX1.16IN PRN-CAPY NON-PVC NEEDLE CAP DISLODGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PATIENT UNDERWENT PELVIC CONTRAST HYPERBARIC INJECTION OF IOHEXOL EN ROUTE TO THE NEEDLE CAP DISLODGED, RESULTING IN INCOMPLETE INJECTION OF THE DRUG AND AFFECTING THE DIAGNOSIS OF THE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398009 BD PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3093694

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other