BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 13286037 · Received January 18, 2022

    Report

    Report Number
    3014704491-2022-00002
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    November 26, 2021
    Report Date
    February 18, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    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 REPORTED LOT# 1050699 WAS NOT FOUND FOR THE REPORTED CATALOG# 383069. MEDICAL 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED/CORRECTED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE ADAPTER OF THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WAS FOUND BROKEN DURING THE POSTOPERATIVE ANTI-INFLAMMATORY TREATMENT WHEN REMOVING THE STOPCOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON NOVEMBER 26, GENERAL ANESTHESIA WAS PERFORMED IN THE OPERATING ROOM. AFTER SURGERY, THE PATIENT WAS RETURNED TO THE WARD, AND THE INDWELLING NEEDLE WAS USED FOR POSTOPERATIVE ANTI-INFLAMMATORY TREATMENT. WHEN THE INDWELLING NEEDLE WAS CONNECTED TO THE OPERATING ROOM THREE-WAY, AND THE THREE-WAY WAS REMOVED (THE SUPPORTING THREE-WAY WAS BERANT THREE-WAY), THE RUPTURE OF THE Y-SHAPED INTERFACE OF THE INDWELLING NEEDLE WAS FOUND, WHICH WAS TIMELY DISCOVERED WITHOUT SERIOUS ADVERSE EVENTS, BUT THE PATIENT NEEDED A SECOND PUNCTURE." D.1. MEDICAL DEVICE BRAND NAME: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM. D.4. MEDICAL DEVICE CATALOG #: 383716. D.4. MEDICAL DEVICE LOT #: 1050699. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-04-28. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.5. PMA/510(K)#: PENDING. H.4. DEVICE MANUFACTURE DATE: 2021-02-19.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050858. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ADAPTER OF THE BD INTIMA II¿ IV CATHETER PRN ADAPTER WAS FOUND BROKEN DURING THE POSTOPERATIVE ANTI-INFLAMMATORY TREATMENT WHEN REMOVING THE STOPCOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "ON NOVEMBER 26, GENERAL ANESTHESIA WAS PERFORMED IN THE OPERATING ROOM. AFTER SURGERY, THE PATIENT WAS RETURNED TO THE WARD, AND THE INDWELLING NEEDLE WAS USED FOR POSTOPERATIVE ANTI-INFLAMMATORY TREATMENT. WHEN THE INDWELLING NEEDLE WAS CONNECTED TO THE OPERATING ROOM THREE-WAY, AND THE THREE-WAY WAS REMOVED (THE SUPPORTING THREE-WAY WAS BERANT THREE-WAY), THE RUPTURE OF THE Y-SHAPED INTERFACE OF THE INDWELLING NEEDLE WAS FOUND, WHICH WAS TIMELY DISCOVERED WITHOUT SERIOUS ADVERSE EVENTS, BUT THE PATIENT NEEDED A SECOND PUNCTURE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ADAPTER OF THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WAS FOUND BROKEN DURING THE POSTOPERATIVE ANTI-INFLAMMATORY TREATMENT WHEN REMOVING THE STOPCOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON NOVEMBER 26, GENERAL ANESTHESIA WAS PERFORMED IN THE OPERATING ROOM. AFTER SURGERY, THE PATIENT WAS RETURNED TO THE WARD, AND THE INDWELLING NEEDLE WAS USED FOR POSTOPERATIVE ANTI-INFLAMMATORY TREATMENT. WHEN THE INDWELLING NEEDLE WAS CONNECTED TO THE OPERATING ROOM THREE-WAY, AND THE THREE-WAY WAS REMOVED (THE SUPPORTING THREE-WAY WAS BERANT THREE-WAY), THE RUPTURE OF THE Y-SHAPED INTERFACE OF THE INDWELLING NEEDLE WAS FOUND, WHICH WAS TIMELY DISCOVERED WITHOUT SERIOUS ADVERSE EVENTS, BUT THE PATIENT NEEDED A SECOND PUNCTURE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ADAPTER OF THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WAS FOUND BROKEN DURING THE POSTOPERATIVE ANTI-INFLAMMATORY TREATMENT WHEN REMOVING THE STOPCOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) GENERAL ANESTHESIA WAS PERFORMED IN THE OPERATING ROOM. AFTER SURGERY, THE PATIENT WAS RETURNED TO THE WARD, AND THE INDWELLING NEEDLE WAS USED FOR POSTOPERATIVE ANTI-INFLAMMATORY TREATMENT. WHEN THE INDWELLING NEEDLE WAS CONNECTED TO THE OPERATING ROOM THREE-WAY, AND THE THREE-WAY WAS REMOVED (THE SUPPORTING THREE-WAY WAS BERANT THREE-WAY), THE RUPTURE OF THE Y-SHAPED INTERFACE OF THE INDWELLING NEEDLE WAS FOUND, WHICH WAS TIMELY DISCOVERED WITHOUT SERIOUS ADVERSE EVENTS, BUT THE PATIENT NEEDED A SECOND PUNCTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052376 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1050699

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown