BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS

    MDR report key: 18027234 · Received October 29, 2023

    Report

    Report Number
    3014704491-2023-00676
    Event Type
    Malfunction
    Date Received
    October 29, 2023
    Date of Event
    September 23, 2023
    Report Date
    January 8, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903839414
    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

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. COMPLAINT DESCRIPTION: LEAKAGE WITH POWER INJECTOR 2. DHR: THE BATCH NUMBER OF THE COMPLAINED PRODUCT IS 1230445, IS 20G AND PRODUCT CODE IS 383941, PRODUCED ON 2021/09 WITH A TOTAL OF (B)(4) PIECES IN THIS BATCH; INSPECTION PROCESS INSPECTION AND DELIVERY INSPECTION REPORT, THE TEST RESULTS MEET THE PRODUCT STANDARDS, NO ABNORMALITY; 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; 3. THE CUSTOMER DID NOT RETURN ANY SAMPLES OR PHOTOS; 4. TAKE THE RETAINED SAMPLE OF THIS BATCH FOR 45PSI SYSTEM LEAKAGE TEST, AND NO ABNORMALITY WAS FOUND. TEST REPORT REFER TO ATTACHMENT 1; 5. SKU# 383941 IS PEGASUS DEVICE (PVC EXTENSION TUBING), THE INTENDED USE FOR THE BD PEGASUS DEVICE IS THE INTRAVASCULAR ADMINISTRATION OF FLUIDS, USE THIS PRODUCT WITH POWER INJECTORS WILL CAUSE CATHETER LEAKAGE OR PRODUCT DAMAGE. THE INSTRUCTIONS FOR USE WARN THIS. 6.FOR THE MARKET DEMAND, BD PLANT SPECIALLY MANUFACTURE;S PEGASUS PLUS DEVICES FOR POWER INJECTORS. THE CODE IS 383745 TO SUM UP,NO ABNORMALITY IS FOUND ON PROCESS AND THE RETAINED SAMPLE. SKU# 383941 IS PEGASUS DEVICE (PVC EXTENSION TUBING), THE INTENDED USE FOR THE BD PEGASUS DEVICE IS THE INTRAVASCULAR ADMINISTRATION OF FLUIDS. USE OF THIS PRODUCT WITH POWER INJECTORS WILL CAUSE CATHETER LEAKAGE OR PRODUCT DAMAGE. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED TO BE RELATED TO PRODUCT QUALITY.

    Additional Manufacturer Narrative · 0

    1.DHR/BHR REVIEW: (1)THE BATCH NUMBER OF THE COMPLAINED PRODUCT IS 1230445, IS 20G AND PRODUCT CODE IS 383941,PRODUCED ON 2021/09 WITH A TOTAL OF 38000 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. THE CUSTOMER DID NOT RETURN SAMPLES AND PROVIDED 3 PHOTOS AND 1 VIDEO. FROM PHOTO 1, IT APPEARS THAT LIQUID IS LEAKING FROM THE SEPTUM; FROM THE VIDEO, IT CAN BE SEEN THAT THERE IS ALSO LIQUID LEAKAGE FROM THE EXTENSION TUBE AT THE CLAMP; PHOTO 3 SHOWS THE INJECTION PARAMETERS USED BY THE CUSTOMER. THE SCREEN DISPLAYS A PRESSURE OF 300PSI, WITH A TEST SALINE FLOW RATE OF 5.0ML/S AND AN INJECTION MEDICAMENT FLOW RATE OF 4.5ML/S, THE USAGE CONDITION WAS HIGH-PRESSURE INJECTION; 3. TAKE THE RETAINED SAMPLE OF THIS BATCH FOR 45PSI SYSTEM LEAKAGE TEST, AND NO ABNORMALITY WAS FOUND. TEST REPORT REFER TO ATTACHMENT 1; 4. SKU#383941 IS PEGASUS DEVICE (PVC EXTENSION TUBING), THE INTENDED USE FOR THE BD PEGASUS DEVICE IS THE INTRAVASCULAR ADMINISTRATION OF FLUIDS, USE THIS PRODUCT WITH POWER INJECTORS WILL CAUSE CATHETER LEAKAGE OR PRODUCT DAMAGE. THE INSTRUCTIONS FOR USE WARN THIS. 5.FOR THE MARKET DEMAND, BD PLANT SPECIALLY MANUFACTURE;S PEGASUS PLUS DEVICES FOR POWER INJECTORS. THE CODE IS 383745. TO SUM UP,NO ABNORMALITY IS FOUND ON PROCESS AND THE RETAINED SAMPLE. SKU#383941 IS PEGASUS DEVICE (PVC EXTENSION TUBING), THE INTENDED USE FOR THE BD PEGASUS DEVICE IS THE INTRAVASCULAR ADMINISTRATION OF FLUIDS. THE CUSTOMER USED THIS PRODUCT UNDER HIGH PRESSURE,USE OF THIS PRODUCT WITH POWER INJECTORS WILL CAUSE CATHETER LEAKAGE OR PRODUCT DAMAGE. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED TO BE RELATED TO PRODUCT QUALITY. H3 OTHER TEXT : SEE NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS PNK 20GA LEAKED FROM THE INSERTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; WHEN THE PATIENT UNDERWENT CORONARY CTA EXAMINATION, ONE END OF THE HIGH-PRESSURE SYRINGE WAS CONNECTED TO THE INTERFACE OF THE INDWELLING NEEDLE, THE EXAMINATION BEGAN TO ADMINISTER THE DRUG, THE LIQUID FLOW RATE WAS 5ML/S, AT THE BEGINNING STAGE, THE PATIENT DICTATED THE SOUND OF "EXPLOSION", THE MEDICAL STAFF PRESENT HEARD THE PATIENT'S SHOUT, STOPPED THE EXAMINATION FOR THE FIRST TIME, ENTERED THE CT ROOM TO CHECK THE SITUATION, CHECKED THAT NO SWELLING WAS FOUND AT THE NEEDLE HOLE OF THE INDWELLING NEEDLE, ASKED THE PATIENT, THE PATIENT DICTATED THAT THERE WAS NO PAIN, BUT HEARD THE "EXPLOSION" THE SOUND OF THE SOUND, RANDOMLY CHECKED, FOUND THAT THERE WAS NO ABNORMALITY AT THE JOINT, BUT THERE WAS A SPRAY OF LIQUID NEAR THE PATIENT'S ARM AND NEAR THE INDWELLING NEEDLE. CAUSING THE PATIENT'S PSYCHOLOGICAL TENSION, FEAR, RESULTING IN THE FIRST EXAMINATION WAS NOT COMPLETED, PART OF THE DRUG LIQUID ENTERED THE PATIENT'S BODY, AND IN DESPERATION, THE SECOND PUNCTURE WAS CARRIED OUT, AND THE SECOND EXAMINATION WAS CARRIED OUT, CAUSING UNNECESSARY PAIN AND INJURY TO THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    PHOTOGRAPHS OF AFFECTED DEVICE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156873 BD PEGASUS INTRAVASCUALR CATHETER FOZ BD (SUZHOU) 1230445 00382903839414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown