BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS BL 22GA X 0.75IN PRN NON-PVC

    MDR report key: 12929766 · Received December 3, 2021

    Report

    Report Number
    3014704491-2021-00323
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    September 16, 2021
    Report Date
    December 20, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1110645 . OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED WHEN USING THE BD PEGASUS BL 22GA X 0.75IN PRN NON-PVC THERE WAS LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE PATIENT WAS SUFFERING FROM COLON CANCER. AT 9:00 A.M. ON (B)(6) 2021, THE RADIOLOGY NURSE FOUND BLOOD OOZING FROM THE INDWELLING NEEDLE CONNECTOR WHEN PLACING THE INDWELLING NEEDLE TO DRAW BLOOD BEFORE PERFORMING ENHANCED CT.WHEN THIS SITUATION WAS FOUND, THE NURSE IMMEDIATELY REMOVED THE INDWELLING NEEDLE AND PERFORMED HEMOSTASIS TREATMENT IN TIME. AT THE SAME TIME, NO BLEEDING OCCURRED AFTER REPLACING THE NEW INDWELLING NEEDLE.CT WAS PERFORMED NORMALLY, PRESENTING THE PATIENT WITH REPEATED PUNCTURE ADVERSE EVENTS.THE MANUFACTURER HAS BEEN INFORMED TO REPLACE IT.ADR# (B)(4). GOOGEL TRANSLATION THE PATIENT WAS DIAGNOSED WITH COLON CANCER. AT 9 AM ON (B)(6) 2021, THE RADIOLOGY NURSE FOUND THAT THERE WAS BLOOD LEAKING FROM THE INDWELLING NEEDLE JOINT WHEN THE INDWELLING NEEDLE WAS PLACED TO DRAW BACK BLOOD BEFORE PERFORMING ENHANCED CT ON THE PATIENT. UPON DISCOVERING THIS SITUATION, THE NURSE IMMEDIATELY REMOVED THE INDWELLING NEEDLE AND PERFORMED HEMOSTATIC TREATMENT IN TIME. AT THE SAME TIME, AFTER REPLACING THE INDWELLING NEEDLE WITH A NEW ONE, THERE WAS NO BLEEDING. CT IS PERFORMED NORMALLY, CAUSING ADVERSE EVENTS OF REPEATED PUNCTURE TO THE PATIENT. THE MANUFACTURER HAS BEEN NOTIFIED TO REPLACE IT. ADR# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PEGASUS BL 22GA X 0.75IN PRN NON-PVC THERE WAS LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE PATIENT WAS SUFFERING FROM COLON CANCER. AT 9:00 A.M. ON (B)(6) 2021, THE RADIOLOGY NURSE FOUND BLOOD OOZING FROM THE INDWELLING NEEDLE CONNECTOR WHEN PLACING THE INDWELLING NEEDLE TO DRAW BLOOD BEFORE PERFORMING ENHANCED CT. WHEN THIS SITUATION WAS FOUND, THE NURSE IMMEDIATELY REMOVED THE INDWELLING NEEDLE AND PERFORMED HEMOSTASIS TREATMENT IN TIME. AT THE SAME TIME, NO BLEEDING OCCURRED AFTER REPLACING THE NEW INDWELLING NEEDLE. CT WAS PERFORMED NORMALLY, PRESENTING THE PATIENT WITH REPEATED PUNCTURE ADVERSE EVENTS. THE MANUFACTURER HAS BEEN INFORMED TO REPLACE IT. (B)(4). (B)(6) TRANSLATION: THE PATIENT WAS DIAGNOSED WITH COLON CANCER. AT 9 AM ON (B)(6) 2021, THE RADIOLOGY NURSE FOUND THAT THERE WAS BLOOD LEAKING FROM THE INDWELLING NEEDLE JOINT WHEN THE INDWELLING NEEDLE WAS PLACED TO DRAW BACK BLOOD BEFORE PERFORMING ENHANCED CT ON THE PATIENT. UPON DISCOVERING THIS SITUATION, THE NURSE IMMEDIATELY REMOVED THE INDWELLING NEEDLE AND PERFORMED HEMOSTATIC TREATMENT IN TIME. AT THE SAME TIME, AFTER REPLACING THE INDWELLING NEEDLE WITH A NEW ONE, THERE WAS NO BLEEDING. CT IS PERFORMED NORMALLY, CAUSING ADVERSE EVENTS OF REPEATED PUNCTURE TO THE PATIENT. THE MANUFACTURER HAS BEEN NOTIFIED TO REPLACE IT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820735 BD PEGASUS BL 22GA X 0.75IN PRN NON-PVC INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1110645

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown