BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS YEL 24GA X 0.75IN PRN-CAP Y

    MDR report key: 10639660 · Received October 6, 2020

    Report

    Report Number
    8041187-2020-00646
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    July 28, 2020
    Report Date
    October 26, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9173717. 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 H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEGASUS YEL 24GA X 0.75IN PRN-CAP Y CATHETER WAS DEFECTIVE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2020/09/19 CLARIFY THE EVENT DESCRIPTION: AT 14:00 ON (B)(6) 2020, WHEN A NURSE PLACED AN INDWELLING NEEDLE FOR A PATIENT WITH A LEFT HUMERAL SHAFT FRACTURE, WHEN IT ENTERED THE PATIENT¿S BLOOD VESSEL, IT WAS FOUND THAT THERE WAS BLOOD OOZING AT THE INSERTION SITE. AFTER REMOVE THE INDWELLING NEEDLE, IT WAS FOUND THAT CATHETER SEPARATE WITH THE NEEDLE CORE , THUS THE PATIENT HAS TO RE-SITING THE INDWELLING NEEDLE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEGASUS YEL 24GA X 0.75IN PRN-CAP Y CATHETER WAS DEFECTIVE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2020/09/19 CLARIFY THE EVENT DESCRIPTION: AT 14:00 ON (B)(6) 2020, WHEN A NURSE PLACED AN INDWELLING NEEDLE FOR A PATIENT WITH A LEFT HUMERAL SHAFT FRACTURE, WHEN IT ENTERED THE PATIENT¿S BLOOD VESSEL, IT WAS FOUND THAT THERE WAS BLOOD OOZING AT THE INSERTION SITE. AFTER REMOVE THE INDWELLING NEEDLE, IT WAS FOUND THAT CATHETER SEPARATE WITH THE NEEDLE CORE , THUS THE PATIENT HAS TO RE-SITING THE INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104503 PEGASUS YEL 24GA X 0.75IN PRN-CAP Y CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9173717

    Patients

    Seq Age Sex Outcome Treatment
    1 Other