BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PHASEAL OPTIMA CONNECTOR (C35-O)

    MDR report key: 10891085 · Received November 24, 2020

    Report

    Report Number
    3003152976-2020-00516
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    October 14, 2020
    Report Date
    November 6, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. INVESTIGATION CONCLUSION: BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. ROOT CAUSE DESCRIPTION: BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA CONNECTOR (C35-O) WAS NOT FULLY ATTACHED TO THE SQ NEEDLE AND LEAKED VELCADE CHEMOTHERAPY MEDICATION ONTO THE PATIENT AND HEALTH CARE WORKER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHE UPDATED ME ON THE CHEMO SPILL INCIDENT THAT OCCURRED WITH OPTIMA. SHE COULD NOT GIVE ANY FULL DETAILS SINCE IT¿S A PEARL EVENT FOR THEIR FACILITY WITH POSSIBLE LIABLE ASPECTS. WHAT OCCURRED WAS EXACTLY WHAT I PREVIOUSLY MENTIONED, THE NURSE DID NOT ATTACH THE C35-O CONNECTOR FULLY TO THE SQ NEEDLE, SO UPON ADMINISTRATION THE VELCADE FLUID LEAKED ONTO THE PATIENT. ALSO, DUE TO THE TECH STILL STRUGGLING WITH SPIKING A SECONDARY SET INTO THE C100-O INFUSION ADAPTER, THEY HAVE CONVERTED BACK TO EQUASHIELD USAGE. I RE-MENTIONED THE SMARTSITE SECONDARY TUBING AS A VIABLE OPTION MOVING FORWARD. "CHEMO EXPOSURE TO PATIENT AND HCWS CUSTOMER STATES THAT CHEMO SPILL OCCURRED DURING SUB Q ADMINISTRATION AND "GOT ALL OVER PATIENT"."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357271 BD PHASEAL OPTIMA CONNECTOR (C35-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other