BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 17101072 · Received June 9, 2023

    Report

    Report Number
    8041187-2023-00265
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    March 13, 2023
    Report Date
    July 30, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903837144
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 01MAY2023. H6: INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2231205. 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. ADDITIONALLY A SAMPLE WAS RETURNED TO OUR FACILITY TO AID IN OUR INVESTIGATION. OUR ENGINEERS NOTED THAT THE QSYTE COMPONENT WAS CONTAMINATED WITH A SMALL BLACK FOREIGN MATERIAL. CLOSER INSPECTION OF THE MATERIAL FURTHER IDENTIFIED THE MATERIAL AS A FIBER OR HAIR LIKE STRUCTURE THAT MOST LIKELY ORIGINATED FORM THE PACKAGING PERSONNEL. TO PREVENT FUTURE OCCURRENCES OF THIS EVENT OUR FACILITY HAS ISSUED A RETAINING OF THE RESPONSIBLE PERSONNEL.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2231205. 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. ADDITIONALLY A SAMPLE WAS RETURNED TO OUR FACILITY TO AID IN OUR INVESTIGATION. OUR ENGINEERS NOTED THAT THE QSYTE COMPONENT WAS CONTAMINATED WITH A SMALL BLACK FOREIGN MATERIAL. CLOSER INSPECTION OF THE MATERIAL FURTHER IDENTIFIED THE MATERIAL AS A FIBER OR HAIR LIKE STRUCTURE THAT MOST LIKELY ORIGINATED FORM THE PACKAGING PERSONNEL. TO PREVENT FUTURE OCCURRENCES OF THIS EVENT OUR FACILITY HAS ISSUED A RETAINING OF THE RESPONSIBLE PERSONNEL. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM THE ADAPTOR WAS DEFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN OPENED FOR USE, A FOREIGN OBJECT WAS FOUND IN THE Q-SYTE CONNECTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING (BRAND NAME) THE ADAPTOR WAS DEFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN OPENED FOR USE, A FOREIGN OBJECT WAS FOUND IN THE Q-SYTE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552174 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2231205 00382903837144

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown