BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA INJECTOR (N35-O)

    MDR report key: 9098452 · Received September 20, 2019

    Report

    Report Number
    3003152976-2019-00642
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Date of Event
    September 5, 2019
    Report Date
    September 30, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905150037
    PMA / PMN Number
    K181221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE CATALOG NUMBER HAS BEEN UPDATED. THE FOLLOWING INFORMATION HAS BEEN CORRECTED: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N35-O) SEPARATED FROM THE PATIENT'S LINE THREE TIMES DURING USE DUE TO A LOOSE CONNECTION BETWEEN IT AND THE CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PER THE NURSE THE CONNECTION POPPED OFF THE PATIENT¿S LINE 3 X BEFORE SHE SWITCHED OUT THE TUBING THE CONNECTORS. NO CHEMO SPILLED AS A RESULT. IT WAS A NEW CONNECTOR INITIALLY BUT NEVER COMPLETELY SNAPPED SNUGGLY TO BEGIN WITH." MEDICAL DEVICE BRAND NAME: BD PHASEAL¿ OPTIMA INJECTOR (N35-O). MEDICAL DEVICE CATALOG#: 515052. UNIQUE IDENTIFIER (UDI) #: (B)(4). PMA / 510(K)#: K181221.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT AND A ROOT CAUSE COULD BE DETERMINED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N35-O) SEPARATED FROM THE PATIENT'S LINE THREE TIMES DURING USE DUE TO A LOOSE CONNECTION BETWEEN IT AND THE CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PER THE NURSE THE CONNECTION POPPED OFF THE PATIENT¿S LINE 3 X BEFORE SHE SWITCHED OUT THE TUBING THE CONNECTORS. NO CHEMO SPILLED AS A RESULT. IT WAS A NEW CONNECTOR INITIALLY BUT NEVER COMPLETELY SNAPPED SNUGGLY TO BEGIN WITH."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N35-O) SEPARATED FROM THE PATIENT'S LINE THREE TIMES DURING USE DUE TO A LOOSE CONNECTION BETWEEN IT AND THE CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PER THE NURSE THE CONNECTION POPPED OFF THE PATIENT¿S LINE 3 X BEFORE SHE SWITCHED OUT THE TUBING THE CONNECTORS. NO CHEMO SPILLED AS A RESULT. IT WAS A NEW CONNECTOR INITIALLY BUT NEVER COMPLETELY SNAPPED SNUGGLY TO BEGIN WITH."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PHASEAL¿ INJECTOR LUER LOCK N35 SEPARATED FROM THE PATIENT'S LINE THREE TIMES DURING USE DUE TO A LOOSE CONNECTION BETWEEN IT AND THE CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PER THE NURSE THE CONNECTION POPPED OFF THE PATIENT¿S LINE 3 X BEFORE SHE SWITCHED OUT THE TUBING THE CONNECTORS. NO CHEMO SPILLED AS A RESULT. IT WAS A NEW CONNECTOR INITIALLY BUT NEVER COMPLETELY SNAPPED SNUGGLY TO BEGIN WITH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895198 BD PHASEAL¿ OPTIMA INJECTOR (N35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN 30382905150037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other