BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTOR LUER LOCK C45

    MDR report key: 8619911 · Received May 17, 2019

    Report

    Report Number
    3003152976-2019-00332
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 23, 2019
    Report Date
    July 12, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905152024
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1804105, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. EVALUATION OF THE CONNECTOR DESIGN WAS COMPLETED BY RESEARCH AND DEVELOPMENT TEAM, AND NO DESIGN RELATED POTENTIAL CAUSES WERE IDENTIFIED THAT COULD CONTRIBUTE TO THE FLOW ISSUE FAILURE MODE THAT WAS OBSERVED. THESE COMPLAINTS WERE ALSO EVALUATED FOR USE CONSIDERATIONS AND OUTSIDE OF CLOGGING FROM UNDISSOLVED DRUG DURING PREPARATION, NO OTHER POTENTIAL CAUSES WERE IDENTIFIED FROM THE PRODUCT USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A FLOW ISSUE WHERE INJECTOR/CONNECTOR DID NO BACKPRIME INTO SECONDARY INFUSION WITH A BD CONNECTOR LUER LOCK C45. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 515202 BATCH NO. 1804105 IT WAS REPORTED THAT THE INJECTOR/CONNECTOR DID NOT ALLOW THE RN TO BE ABLE TO BACKPRIME NS INTO A SECONDARY INFUSION. "INTERESTINGLY ENOUGH¿ WE HAD ANOTHER PHASEAL ISSUE OVERNIGHT WHERE THE INJECTOR/CONNECTOR DID NOT ALLOW THE RN TO BE ABLE TO BACKPRIME NS INTO A SECONDARY INFUSION. THERE IS A SAFETY REPORT IN--- 254045. THE RN REMOVED AND REPLACED THE PHASEAL WITH NO SUCCESS. WHAT WAS CONCERNING WAS THAT SHE WAS ADVISED BY PHARMACY OVERNIGHT TO ¿SPIKE AND REPRIME YOURSELF¿¿ WHICH THE RN DID NOT DO AS IT IS NOT CONSISTENT WITH OUR SAFE HANDLING STANDARDS. ENDED UP USING THIS MORNING¿S DOSE AND IT WAS ABLE TO BE BACK-PRIMED.' CONNECTOR IS REF 515202, LOT IS 1804105

    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 THERE WAS A FLOW ISSUE WHERE INJECTOR/CONNECTOR DID NO BACKPRIME INTO SECONDARY INFUSION WITH A BD CONNECTOR LUER LOCK C45. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 515202, BATCH NO. 1804105. IT WAS REPORTED THAT THE INJECTOR/CONNECTOR DID NOT ALLOW THE RN TO BE ABLE TO BACKPRIME NS INTO A SECONDARY INFUSION. "INTERESTINGLY ENOUGH¿ WE HAD ANOTHER PHASEAL ISSUE OVERNIGHT WHERE THE INJECTOR/CONNECTOR DID NOT ALLOW THE RN TO BE ABLE TO BACKPRIME NS INTO A SECONDARY INFUSION. THERE IS A SAFETY REPORT IN--- 254045. THE RN REMOVED AND REPLACED THE PHASEAL WITH NO SUCCESS. WHAT WAS CONCERNING WAS THAT SHE WAS ADVISED BY PHARMACY OVERNIGHT TO ¿SPIKE AND REPRIME YOURSELF¿¿ WHICH THE RN DID NOT DO AS IT IS NOT CONSISTENT WITH OUR SAFE HANDLING STANDARDS. ENDED UP USING THIS MORNING¿S DOSE AND IT WAS ABLE TO BE BACK-PRIMED.' CONNECTOR IS REF 515202, LOT IS 1804105.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415313 BD CONNECTOR LUER LOCK C45 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1804105 30382905152024

    Patients

    Seq Age Sex Outcome Treatment
    1 Other