BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 11159439 · Received January 13, 2021

    Report

    Report Number
    8041187-2021-00018
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 13, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR POSSIBLE LOT 0055001 AND NO ABNORMALITIES WERE FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEMS EXPERIENCED DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 24G PEGASUS WAS USED IN 400 EMERGENCY RESCUE AREA OF THE USER FACILITY, THE LEAKAGE WAS FOUND FOR MANY TIMES, FORMS A FRACTURE EXTENSION TUBE AND JOINT GAP, PART DURING THE EXHAUST TO NURSE THE PATIENT BEFORE THE BED OPEN THE PACKING, FOUND THAT PART WERE FOUND IN THE PROCESS OF PIERCING. NEEDLE EXTENSION TUBE CONNECTED TO THE RUHR JOINT POSITION BLOOD LEAKAGE. THE CLINICAL NURSE COMPLAINED THAT THERE WERE MANY CASES OF RUPTURE AND FRACTURE OF THE CATHETER, AND AFTER CONFIRMING WITH THE HEAD NURSE TO TAKE PHOTOS AND COLLECT EVIDENCE, SHE REPORTED TO THE EQUIPMENT DEPARTMENT AND ASKED FOR COMPENSATION FOR THE CORRESPONDING NUMBER OF INDWELLS. THE HOSPITAL DID NOT RETAIN THE QUALITY PROBLEM AND DID NOT PROVIDE THE QUALITY PROBLEM LIEN NEEDLE, SO THE PROBLEM PRODUCT COULD NOT BE SENT BACK TO THE COMPANY FOR ANALYSIS. SUCH PROBLEMS HAVE OCCURRED MORE, THE HOSPITAL ATTACHES GREAT IMPORTANCE TO THIS PROBLEM, THERE IS NO SERIOUS MEDICAL ACCIDENT.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEMS EXPERIENCED DEFECTIVE/DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 24G PEGASUS WAS USED IN 400 EMERGENCY RESCUE AREA OF THE USER FACILITY, THE LEAKAGE WAS FOUND FOR MANY TIMES, FORMS A FRACTURE EXTENSION TUBE AND JOINT GAP, PART DURING THE EXHAUST TO NURSE THE PATIENT BEFORE THE BED OPEN THE PACKING, FOUND THAT PART WERE FOUND IN THE PROCESS OF PIERCING. NEEDLE EXTENSION TUBE CONNECTED TO THE RUHR JOINT POSITION BLOOD LEAKAGE. THE CLINICAL NURSE COMPLAINED THAT THERE WERE MANY CASES OF RUPTURE AND FRACTURE OF THE CATHETER, AND AFTER CONFIRMING WITH THE HEAD NURSE TO TAKE PHOTOS AND COLLECT EVIDENCE, SHE REPORTED TO THE EQUIPMENT DEPARTMENT AND ASKED FOR COMPENSATION FOR THE CORRESPONDING NUMBER OF INDWELLS. THE HOSPITAL DID NOT RETAIN THE QUALITY PROBLEM AND DID NOT PROVIDE THE QUALITY PROBLEM LIEN NEEDLE, SO THE PROBLEM PRODUCT COULD NOT BE SENT BACK TO THE COMPANY FOR ANALYSIS. SUCH PROBLEMS HAVE OCCURRED MORE, THE HOSPITAL ATTACHES GREAT IMPORTANCE TO THIS PROBLEM, THERE IS NO SERIOUS MEDICAL ACCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56518 BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1