BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 9662468 · Received February 3, 2020

    Report

    Report Number
    3006948883-2020-00050
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 14, 2020
    Report Date
    February 24, 2020
    Manufacturer
    BD (SUZHOU)
    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 9141633. 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 THE DEVICE SUBMITTED TO OUR FACILITY WAS EVALUATED BY OUR QUALITY INSPECTORS, THEY WERE ABLE TO CONFIRM THE PRESENCE OF A HAIRLINE CRACK IN THE ADAPTER HEAD. THE ASSEMBLY RECORD ASSOCIATED WITH LOT 9141633 DID NOT CONTAIN ANY RECORDINGS FOR VARIATION IN SWAGE DEPTH OR ADAPTER FLARING DIMENSIONS. UNFORTUNATELY, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW, HOWEVER OUR FACILITY HAS ISSUED A RETRAINING OF THE INSPECTION PERSONNEL TO IDENTIFY AND SEGREGATE NON-CONFORMING MATERIAL IN ACCORDANCE WITH STANDARD PROCEDURES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED FROM THE CONNECTION BETWEEN THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM EXTENSION TUBING AND SEPTUM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "IT'S NOTICED THAT LEAKAGE DURING USAGE. WHICH WAS SUSPECTED THAT SEPTUM SEPARATION FROM THE EXT. TUBING AND RESULT IN LEAKAGE AT THE CONNECTION SITE BETWEEN THE SEPTUM AND EXT. TUBING".

    Additional Manufacturer Narrative · 1

    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 LEAKAGE OCCURRED FROM THE CONNECTION BETWEEN THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM EXTENSION TUBING AND SEPTUM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(4) TO ENGLISH: "IT'S NOTICED THAT LEAKAGE DURING USAGE. WHICH WAS SUSPECTED THAT SEPTUM SEPARATION FROM THE EXT. TUBING AND RESULT IN LEAKAGE AT THE CONNECTION SITE BETWEEN THE SEPTUM AND EXT. TUBING"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126200 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9141633

    Patients

    Seq Age Sex Outcome Treatment
    1 Other