BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA CONNECTOR (C35-O)

    MDR report key: 12631638 · Received October 14, 2021

    Report

    Report Number
    3003152976-2021-00685
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 13, 2021
    Report Date
    November 5, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150562
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD PHASEAL¿ OPTIMA CONNECTOR (C35-O) THERE WAS A INJECTOR LOOSE OR SEPARATION OF THE INJECTOR AND MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PHASEAL OPTIMA INJECTOR DISCONNECTED FROM THE LUER LOCK. REPORTED BY PATIENT: SHE FELT SOMETHING WET ON HER HAND AND SHIRT. WHEN CHECKED BY RN, FOUND THE PATIENT HOLDING THE TUBING WITH TIP OF THE NEW BD PHASEAL OPTIMA INJECTOR DISCONNECTED FROM THE LUER LOCK. CHANGED THE DISCONNECTED TUBING AND NEW TACRO SET UP PREPARED. ASSISTED PATIENT TO WASH HANDS AND ARMS AND TO MONITOR ANY SKIN ISSUE." D.1. MEDICAL DEVICE BRAND NAME: BD PHASEAL¿ OPTIMA CONNECTOR (C35-O). D.4. MEDICAL DEVICE CATALOG #: 515070. D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.4. PMA / 510(K)#: K181221. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.6. INVESTIGATION: ONE PHOTO RECEIVED FOR INVESTIGATION, ONE OPTIMA INJECTOR N40-O LUER CONNECTED TO A IV TUBING AND AT THE SAME TIME CONNECTED TO AN OPTIMA CONNECTOR. OPTIMA CONNECTOR WAS LUER DISCONNECTED FROM THE Y-SITE FROM THE IV TUBING. BASED ON PICTURE RECEIVED; NO DAMAGES OR ISSUES WERE FOUND ON OPTIMA INJECTOR NOR OPTIMA CONNECTOR. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PHASEAL¿ OPTIMA CONNECTOR (C35-O) THERE WAS A INJECTOR LOOSE OR SEPARATION OF THE INJECTOR AND MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PHASEAL OPTIMA INJECTOR DISCONNECTED FROM THE LUER LOCK. REPORTED BY PATIENT: SHE FELT SOMETHING WET ON HER HAND AND SHIRT. WHEN CHECKED BY RN, FOUND THE PATIENT HOLDING THE TUBING WITH TIP OF THE NEW BD PHASEAL OPTIMA INJECTOR DISCONNECTED FROM THE LUER LOCK. CHANGED THE DISCONNECTED TUBING AND NEW TACRO SET UP PREPARED. ASSISTED PATIENT TO WASH HANDS AND ARMS AND TO MONITOR ANY SKIN ISSUE."

    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 WHEN USING THE BD PHASEAL¿ OPTIMA INJECTOR (N40-O) THERE WAS A INJECTOR LOOSE OR SEPARATION OF THE INJECTOR AND MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PHASEAL OPTIMA INJECTOR DISCONNECTED FROM THE LUER LOCK. REPORTED BY PATIENT: SHE FELT SOMETHING WET ON HER HAND AND SHIRT. WHEN CHECKED BY RN, FOUND THE PATIENT HOLDING THE TUBING WITH TIP OF THE NEW BD PHASEAL OPTIMA INJECTOR DISCONNECTED FROM THE LUER LOCK. CHANGED THE DISCONNECTED TUBING AND NEW TACRO SET UP PREPARED. ASSISTED PATIENT TO WASH HANDS AND ARMS AND TO MONITOR ANY SKIN ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534028 BD PHASEAL¿ OPTIMA CONNECTOR (C35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515056 UNKNOWN 00382905150562

    Patients

    Seq Age Sex Outcome Treatment
    1 Female