BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ FEMALE LUER LOCK ADAPTER

    MDR report key: 16747800 · Received April 14, 2023

    Report

    Report Number
    2243072-2023-00625
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    November 18, 2022
    Report Date
    May 15, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    10885403484353
    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

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS US MOLDING COE. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 15-MAY-2023. INVESTIGATION SUMMARY: A COMPLAINT OF COMPONENT CRACKING PRIOR TO USE WITH NO FORCE APPLIED WAS RECEIVED FROM THE CUSTOMER. THIS COMPONENT IS SUPPLIED BY THE NORTH AMERICAN MOLDING CENTER (NAMC), SO THEY WERE NOTIFIED OF THIS COMPLAINT. BD NAMC RECEIVED THE SAMPLES FOR FURTHER INVESTIGATION: 2 SETS FROM LOT NUMBER 0004081218 AND 17 SETS OF SAMPLES FROM LOT NUMBER 2200510, AND NO SAMPLES FROM LOT NUMBER 2153003. THE SAMPLES PROVIDED WERE BRITTLE IN NATURE FROM THE LOT PRODUCED AT BD AND VYAIRE. THE DEVICE HISTORY REVIEW WAS PERFORMED FOR THE BATCHES PRODUCED AT NAMC. BASED ON THE REVIEW, THE CONE TESTING IS PERFORMED AT A FREQUENCY OF 2 SHOTS EVERY SHIFT (SHIFT START AND MIDDLE OF THE SHIFT) AS A PART OF IN PROCESS INSPECTION DURING THE PRODUCTION OF THIS PART CODE. THE RESULTS OF THE CONE TESTING WERE ACCEPTABLE AND RECORDED ON THE DEVICE HISTORY PAPERWORK. A QUALITY NOTIFICATION WAS FOUND FOR THE REPORTED LOT 2153003 AND WAS CREATED AS A PART OF A GLOBAL HOLD PROCESS TO CONTAIN THIS BATCH FROM BEING USED AND SHIPPED OUT OF THE BD WAREHOUSE. THERE WAS A PROCESS CHANGE CONTROL IMPLEMENTED FOR THE PRESS USED FOR THE PRODUCTION OF THIS MATERIAL, WHICH ENABLES THE PRESS TO BE ON A MANDATORY PURGING REQUIREMENT WHEN THERE IS A DOWNTIME EXCEEDING 3 MINUTES AND THE PRESS WILL NOT MOVE TO THE AUTOMATIC PRODUCTION MODE UNTIL THE MATERIAL (CO-POLYESTER) IS COMPLETELY PURGED OUT FROM THE BARREL. THIS ACTION WAS TAKEN DUE TO THE PROPERTY OF THE CO-POLYESTER BECOMING BRITTLE DUE TO EXPOSURE TO PROLONGED HIGH TEMPERATURE. INVESTIGATION WAS PERFORMED AT NAMC WITH THE MOLDING ENGINEERING, PROCESS ENGINEERING, PRODUCTION AND CONTROLS ENGINEERING GROUP, REGARDING THE COMPLAINT AND THE DEFECT PRESENT. THE MOLD 00309 PRODUCES 3 DIFFERENT PART CODES 1024-34-043, 1024-162-043, AND 1024-156-043. ALL THESE PART CODES UTILIZE THE CO-POLYESTER RESIN MATERIAL. AS MENTIONED EARLIER IN THE DHR REVIEW, A PROCESS CHANGE CONTROL WAS COMPLETED ON 26AUG2022 TO ADD THE MANDATORY AUTO PURGING FUNCTION ON THE MOLDING PRESS. BOTH THE AFFECTED BATCHES WERE PRODUCED BEFORE THE IMPLEMENTATION OF THE FUNCTION. THE ROOT CAUSE RELATED TO THE FLLA PRODUCT BREAKING IS THE BRITTLENESS OF THE CO-POLYESTER WHEN MOLDED AT HIGHER HEAT SETTINGS, DURING THE EVENT OF DOWNTIME AND INSUFFICIENT PURGING OF THE MATERIAL FROM THE BARREL BEFORE STARTING THE NORMAL PRODUCTION CYCLE. THE PRODUCTS FROM LOT NUMBERS 2153003 AND 2200510 WILL BE SCRAPPED. ALL THE CHANGES IMPLEMENTED THROUGH THE PRODUCT CHANGE CONTROL, WERE COMPLETED AFTER THE PRODUCTION OF LOT NUMBER 2208762. HOWEVER, THE ONLY BATCHES AVAILABLE AT THE BD WAREHOUSE CURRENTLY IS LOT NUMBERS 2153003 AND 2208762 WHICH HAVE BEEN PLACED ON GLOBAL HOLD. THE BATCH NUMBERS 2153003 CONTAINING 10,000 PARTS IN THE WAREHOUSE IS PLACED ON HOLD AND WILL BE DISPOSITIONED AS SCRAP. ADDITIONALLY, LOT NUMBER 2208762 PRODUCED FROM PART NUMBER 1024-156-043 USING THE SAME MOLD AND RESIN MATERIAL PRODUCED BEFORE (B)(6) 2022 IS MOVED TO A GLOBAL HOLD FOR FURTHER REVIEW AND DECISION TO RELEASE. NAMC WILL BE MONITORING THE VISUAL INSPECTION RESULTS THROUGH THE QUALITY NOTIFICATIONS FOR ANY NON-CONFORMANCES OBSERVED RELATED TO THE GATE STUB/ GATE PROJECTION THROUGH QUALITY ALERT AWARENESS. THE PROCESS CHANGE CONTROL IMPLEMENTED HAS BEEN EFFECTIVE TO MITIGATE ANY OCCURRENCE RELATED TO CRACK FAILURES DUE TO COMPLETE MANDATORY PURGING FUNCTION ON THE MOLDING PRESS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ FEMALE LUER LOCK ADAPTER THE PRODUCT WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED "CRACK" WHEN TRYING (WITHOUT FORCING) TO TIGHT 3 DIFFERENT FLL ON 2 DIFFERENT STOPCOCKS REFERENCE. WE HAVE HAD FEW COMPLAINT THIS LAST MONTH REGARDING CRACKED/BROKEN FEMALE LUER LOCK (CODAN REF (B)(4) AND BD REF (B)(4)). WE HAVE HAD IN TOTAL 5 COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ FEMALE LUER LOCK ADAPTER THE PRODUCT WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED "CRACK" WHEN TRYING (WITHOUT FORCING) TO TIGHT 3 DIFFERENT FLL ON 2 DIFFERENT STOPCOCKS REFERENCE. WE HAVE HAD FEW COMPLAINT THIS LAST MONTH REGARDING CRACKED/BROKEN FEMALE LUER LOCK (CODAN REF (B)(4).WE HAVE HAD IN TOTAL 5 COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819098 BD¿ FEMALE LUER LOCK ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 0004081218 10885403484353

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown