BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS PNK 20GA X 1.16IN PRN-CAP Y

    MDR report key: 15325619 · Received August 31, 2022

    Report

    Report Number
    3006948883-2022-00170
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    July 30, 2022
    Report Date
    September 11, 2022
    Manufacturer
    BD (SUZHOU)
    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

    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

    THE FOLLOWING FIELDS WERE CORRECTED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 07-SEP-2022. H6: INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY THE FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1201361. 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 PHOTOGRAPH WAS PROVIDED OF A PEGASUS UNIT MISSING A PRN ADAPTER. OUR ENGINEERS HAVE REVIEWED THE MANUFACTURING PROCESS AND BELIEVE THAT THE ROOT CAUSE FOR THIS EVENT IS MOST LIKELY RELATED TO THE MANUALLY ASSEMBLY LINE. DURING ASSEMBLY IT IS POSSIBLE FOR THE ASSEMBLY PERSONNEL TO MISS THE COMPONENT. TO PREVENT FUTURE OCCURRENCES OF THIS EVENT OR ENGINEERS HAVE BEEN RETAINED ON THE APPROPRIATE ASSEMBLY PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS PNK 20GA X 1.16IN PRN-CAP Y EXPERIENCED A MISSING DIAPHRAGM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ACCORDING TO NEUROLOGY 5, WHEN THE PACKAGE WAS OPENED, THERE WAS NO PRN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS PNK 20GA X 1.16IN PRN-CAP Y EXPERIENCED A MISSING DIAPHRAGM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ACCORDING TO NEUROLOGY 5, WHEN THE PACKAGE WAS OPENED, THERE WAS NO PRN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2614852 BD PEGASUS PNK 20GA X 1.16IN PRN-CAP Y CATHETER FOZ BD (SUZHOU) 1201361

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown