BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ CONNECTOR LUER LOCK (C35)

    MDR report key: 12589537 · Received October 7, 2021

    Report

    Report Number
    3003152976-2021-00666
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    September 9, 2021
    Report Date
    December 28, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905152000
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLES FOR THIS COMPLAINT WERE SENT BY THE CUSTOMER; HOWEVER, SAMPLES WILL NOT BE RELEASED BY CUSTOMS AGENCY. NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. FIVE RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, NO ISSUES OR DEFECTS OBSERVED. ALSO, ALL OF THEM COULD BE PROPERLY CONNECTED TO A MATTING COMPONENT. LEAKAGE TESTING IS PERFORMED FOR ALL LOTS DURING MANUFACTURING TO ENSURE THE QUALITY OF THE MEMBRANE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2011213, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE PERFORMANCE OF THE SEALING MEMBRANE IS REDUCED AFTER MULTIPLE PERFORATIONS AND EXTENDED ACTIVATION TIME. IT IS IMPORTANT TO FOLLOW THE INSTRUCTIONS FOR USE WHEN USING PHASEAL DEVICES TO ENSURE THE PRODUCT FUNCTIONS PROPERLY. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ CONNECTOR LUER LOCK (C35) SEPARATED AND LEAKED CHEMOTHERAPY MEDICINE ONTO THE PATIENT'S BED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A NURSE ON OUR FLOOR DISCONNECTED A PATIENTS CHEMO AND IT SPRAYED THE MEDICATION OUT ONTO THE BED. SHE HAD THOUGHT IT WAS THE FEMALE END AT FIRST BECAUSE WHEN SHE LOOKED AT IT THERE WAS FLUID INSIDE THE FEMALE END. BUT THAT MAKES ABSOLUTELY ZERO SENSE BECAUSE IT WAS ATTACHED TO A PICC LINE, SO NOTHING COULD FLUSH BACK. THE PICC WAS FLUSHING EASILY WITHOUT ANY BACK PRESSURE. WE THINK IT WAS ACTUALLY THE MALE END. NUMBERS SO WE WEREN¿T SURE WHICH ONE IT WAS. JUST IN CASE, THE LOT NUMBER FOR THE LUER LOCK CONNECTOR (C35) IS2011213. THE PATIENT HAD CHEMO RUNNING THROUGH, WITH AN INFUSION CLAMP IN PLACE BECAUSE IT IS AN AMBULATORY CHEMO, FOR APPROXIMATELY 23.5 HOURS. CYTOTOXIC EXPOSURE OF MEDICATION ON PATIENT'S BED LINENS."

    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 THE BD PHASEAL¿ CONNECTOR LUER LOCK (C35) SEPARATED AND LEAKED CHEMOTHERAPY MEDICINE ONTO THE PATIENT'S BED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A NURSE ON OUR FLOOR DISCONNECTED A PATIENTS CHEMO AND IT SPRAYED THE MEDICATION OUT ONTO THE BED. SHE HAD THOUGHT IT WAS THE FEMALE END AT FIRST BECAUSE WHEN SHE LOOKED AT IT THERE WAS FLUID INSIDE THE FEMALE END. BUT THAT MAKES ABSOLUTELY ZERO SENSE BECAUSE IT WAS ATTACHED TO A PICC LINE, SO NOTHING COULD FLUSH BACK. THE PICC WAS FLUSHING EASILY WITHOUT ANY BACK PRESSURE. WE THINK IT WAS ACTUALLY THE MALE END. NUMBERS SO WE WEREN'T SURE WHICH ONE IT WAS. JUST IN CASE, THE LOT NUMBER FOR THE LUER LOCK CONNECTOR (C35) IS2011213. THE PATIENT HAD CHEMO RUNNING THROUGH, WITH AN INFUSION CLAMP IN PLACE BECAUSE IT IS AN AMBULATORY CHEMO, FOR APPROXIMATELY 23.5 HOURS. CYTOTOXIC EXPOSURE OF MEDICATION ON PATIENT'S BED LINENS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489739 BD PHASEAL¿ CONNECTOR LUER LOCK (C35) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515200 2011213 30382905152000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown