BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 17839576 · Received September 28, 2023

    Report

    Report Number
    8041187-2023-00514
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    September 13, 2023
    Report Date
    November 3, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THERE WAS A VISUAL INSPECTION TO CHECK FOR FM DURING OUTGOING INSPECTION AS PER MQA-069/C. THERE WAS NO FM QN RAISED FOR FM ON THIS BATCH. 1 PHOTO IS RECEIVED. REFER TO ATTACHMENT A. A BLACK TAPE WAS OBSERVED ON THE TOP WEB OF THE PEGASUS UNITS. 4 SAMPLES WERE RECEIVED. REFER TO ATTACHMENT B. A BLACK TAPE WAS OBSERVED ON THE TOP WEB OF THE 4 PEGASUS UNITS. THE BLACK TAPE IS FROM THE RAW MATERIAL TOP WEB USE TO SPLICE 2 TOP WEBS TOGETHER IN A ROLL. THERE IS A SENSOR ONLINE IN THE PEGASUS LINE TO DETECT ANY TAPE DURING PRODUCTION. THE MACHINE WILL STOP WHEN THERE IS A TAPE DETECTED. THERE WAS NO FAULTY SENSOR DURING THE PRODUCTION OF THIS BATCH. THE POSSIBLE CAUSE OF THE TAPE ON THE 4 RETURNED UNITS COULD LIKELY BE THE PT CUTTING AND RE-JOINING THE TOP WEB MATERIAL AFTER THE SENSOR CAUSING THE TOP WEB NOT DETECTED BY THE SENSOR AFTER THE RE-JOINING. THE COMPLAINT TREND WILL BE TRACKED AND MONITORED. DESCRIPTION OF THE PROPOSED ACTION: 1 PROCEDURE 70005725 TO UPDATE AN INSTRUCTION TO CUT AND RE-JOIN TOP WEB BEFORE THE SENSOR. (ASSIGNED TO PETER NG BOON SIONG, TARGET COMPLETION DATE : 15-DEC-2023) EFFECTIVENESS CHECK PAN: 1 PERFORM 3 RANDOM CHECK ON PT ARE RE-JOINING THE TOP WEB BEFORE THE SENSOR. MONITORING PERIOD: 8 WEEKS AFTER IMPLEMENTATION ACCEPTANCE CRITERIA: ZERO NON-CONFORMITY (ASSIGNED TO PANG KOK HONG, TARGET COMPLETION DATE : 09-FEB-2023)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGE OF 4 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WAS DAMAGED. THE FOLLOWING WAS TRANSLATED FROM CHINESE TO ENGLISH: THE TEACHER FROM THE GENERAL AFFAIRS DEPARTMENT OPENED THE PACKAGE AND FOUND THAT THE INDWELLING NEEDLE PACKAGE WAS COVERED WITH BLACK TAPE. HE RETURNED IT TO THE SALESPERSON. AFTER THE SALESPERSON TORE OFF THE BLACK TAPE, HE FOUND THAT THE PACKAGE WAS DAMAGED AND COULD NOT BE USED CLINICALLY.

    Description of Event or Problem · 0

    THE TEACHER FROM THE GENERAL AFFAIRS DEPARTMENT OPENED THE PACKAGE AND FOUND THAT THE INDWELLING NEEDLE PACKAGE WAS COVERED WITH BLACK TAPE. HE RETURNED IT TO THE SALESPERSON. AFTER THE SALESPERSON TORE OFF THE BLACK TAPE, HE FOUND THAT THE PACKAGE WAS DAMAGED AND COULD NOT BE USED CLINICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2038080 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2291079

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown