BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 8476173 · Received April 2, 2019

    Report

    Report Number
    8041187-2019-00270
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 15, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    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 8235275. OUR RECORDS HAVE IDENTIFIED A TREND IN THE BATCH OF INTIMA-IIS. 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, ALTHOUGH A SAMPLE COULD NOT BE SECURED FOR OUR INVESTIGATION. OUR INVESTIGATORS NOTED PREVIOUS INVESTIGATIONS SHOW THAT THROUGH A VARIANCE IN THE AUTOLINE'S SWAGE PRESSURE IT IS POSSIBLE FOR THE MACHINE TO APPLY EXCESS FORCE TO THE DEVICE DURING ASSEMBLY, ALLOWING FOR THE RESULTING CRACK TO FORM IN THE DEVICE. CURRENTLY, WE ARE CONDUCTING A LONG TERM STUDY TO DETERMINE THE ROOT CAUSE FOR THIS EVENT, BUT WE ARE ADDRESSING THE ISSUE THROUGH THE IMPLEMENTATION OF MANUAL INSPECTION S FOR CRACKS IN THE ADAPTER HEAD, AND WE ARE FURTHER OPTIMIZING OUR SWAGING PROCESS BY REDUCING DEPTH REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXTENSION TUBING LEAKED NEAR THE LUER CONNECTOR DURING RETRACTION WITH A BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON THE MORNING OF (B)(6) 2019, CARDIAC VASCULAR SURGERY NURSE TOOK BD FLY Q TO THE PATIENT PUNCTURE, REMOVE THE NEEDLE CORE, THE BLOOD FROM NEAR THE THREE-WIRE CONNECTING SEAT OF THE EXTENDED PIPE LEAK OUT. SO REPLACE A FLY Q AND PERFORM A PUNCTURE.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTENSION TUBING LEAKED NEAR THE LUER CONNECTOR DURING RETRACTION WITH A BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ON THE MORNING OF (B)(6) 2019, CARDIAC VASCULAR SURGERY NURSE TOOK BD FLY Q TO THE PATIENT PUNCTURE, REMOVE THE NEEDLE CORE, THE BLOOD FROM NEAR THE THREE-WIRE CONNECTING SEAT OF THE EXTENDED PIPE LEAK OUT. SO REPLACE A FLY Q AND PERFORM A PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269735 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8235275

    Patients

    Seq Age Sex Outcome Treatment
    1 Other