BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ FEMALE LUER LOCK ADAPTER

    MDR report key: 17066486 · Received June 5, 2023

    Report

    Report Number
    2243072-2023-00967
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    May 10, 2023
    Report Date
    August 28, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 10-JUL-2023. INVESTIGATION SUMMARY: A COMPLAINT OF COMPONENTS BEING CRACKED AND BROKEN WAS RECEIVED FROM THE CUSTOMER. FROM THE REPORTED LOT NUMBERS, ONE WAS A VYAIRE LOT 0004081218 AND THE OTHER TWO WERE LOTS FROM THE NORTH AMERICAN MOLDING CENTER (NAMC). THE MOLD FOR THIS COMPONENT HAS BEEN MOVED FROM VYAIRE TO NAMC. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE TWO NAMC LOTS. BOTH LOT NUMBERS 2200507 AND 2304725 HAD NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED DEFECT. AN INVESTIGATION WAS PERFORMED AT NAMC. THE RECEIVED SAMPLES WERE INSPECTED FOR DAMAGE, AND NO DEFECT COULD BE SEEN ON THE RETURNED SAMPLES. COMPONENTS ARE INSPECTED WITH CONE TESTING FOR ALL LOTS TO CONFIRM THEY ARE ACCEPTABLE. A MANDATORY AUTOMATED PURGING ROUTINE WAS IMPLEMENTED FOR A DOWNTIME EXCEEDING 3 MINUTES TO PREVENT THIS DEFECT. THIS ROUTINE INCLUDES PURGING OF THE BARREL AND THE HOT RUNNER. OTHER CONTROLS IN PLACE INCLUDE MOISTURE CONTROL CHECKS AT START UP, MOLD PREVENTIVE MAINTENANCE ROUTINE, AND MOLD CLEANING ROUTINE. NAMC WILL BE MONITORING THE VISUAL INSPECTION RESULTS THROUGH A QUALITY NOTIFICATION FOR ANY NON-CONFORMANCES OBSERVED RELATED TO THE CRACK TEST FAILURE THROUGH QUALITY ALERT AWARENESS. THE PROCESS CHANGE CONTROL IMPLEMENTED HAS BEEN EFFECTIVE TO MITIGATE ANY OCCURRENCE RELATED TO CRACK FAILURES DUE TO COMPLETE AND MANDATORY PURGING FUNCTION ON THE MOLDING PRESS. COMPONENT DAMAGE CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS MOLDING COE. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2200507. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 19-JUL-2022 D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. 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 · 0

    IT WAS REPORTED THAT 5 BD¿ FEMALE LUER LOCK ADAPTERS FROM LOT 2200507, AND 3 ADAPTERS FROM AN UNSPECIFIED LOT WERE FOUND CRACKED DURING AN ASSEMBLY LINE INSPECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVEN¿T RECEIVED ANY MORE COMPLAINTS FROM THE CUSTOMER REGARDING THE CRACKED FLL. HOWEVER, OUR PRODUCTION FACILITY DISCOVERED SOME NEW ONE DURING ASSEMBLY OF OUR SET... 100% INSPECTION IS BEING DONE ON THE ASSEMBLY LINE. EVERY ASSEMBLER IS CHECKING FOR CRACKS FOR ANY FLL THAT THEY HANDLE. THEN THEY CONNECT THE FLL TO THE OTHER PART OF THE SET AND CONFIRM THAT THE TIGHTNESS IS BEING DONE CORRECTLY. IF NOT, THEY PUT THE DEFECTIVE FLL AWAY FOR INVESTIGATION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD¿ FEMALE LUER LOCK ADAPTERS FROM LOT 2200507, AND 3 ADAPTERS FROM AN UNSPECIFIED LOT WERE FOUND CRACKED DURING AN ASSEMBLY LINE INSPECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVEN¿T RECEIVED ANY MORE COMPLAINTS FROM THE CUSTOMER REGARDING THE CRACKED FLL. HOWEVER, OUR PRODUCTION FACILITY DISCOVERED SOME NEW ONE DURING ASSEMBLY OF OUR SET. 100% INSPECTION IS BEING DONE ON THE ASSEMBLY LINE. EVERY ASSEMBLER IS CHECKING FOR CRACKS FOR ANY FLL THAT THEY HANDLE. THEN THEY CONNECT THE FLL TO THE OTHER PART OF THE SET AND CONFIRM THAT THE TIGHTNESS IS BEING DONE CORRECTLY. IF NOT, THEY PUT THE DEFECTIVE FLL AWAY FOR INVESTIGATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093162 BD¿ FEMALE LUER LOCK ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown