BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ ONE-WAY VALVE

    MDR report key: 6962107 · Received October 19, 2017

    Report

    Report Number
    9610847-2017-00123
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    September 24, 2017
    Report Date
    December 7, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. THIS IS THE FIRST TIME THAT WE HAVE THIS KIND OF ISSUE RELATED TO THE CUSTOMER DEFECTIVE CHECK VALVE; HOWEVER, THE SAMPLE HAS NOT BEING EVALUATED AT THIS POINT BECAUSE IT WAS SENT TO THE SUPPLIER TO BE EVALUATED WHICH IS ESSENTIAL TO PERFORM A BETTER INVESTIGATION. QUALITY RECORDS HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES AND NO ISSUES LIKE THIS ARE DETECTED WHICH MEANS PRETTY LOW OCCURRENCE. WE WILL KEEP MONITORING THE MANUFACTURING PROCESS AND IN CASE ANY EMERGING TREND IS DETECTED, FURTHER ACTIONS WILL BE TAKEN IF NECESSARY. THE CATALOG 397019 IT IS A CHECK VALVE CONNECTOR THAT IT IS RECEIVED AS A RAW MATERIAL, THEN IT IS PACKED IN A BLISTER AND PLACED INTO A BOX WITH A QUANTITY OF (B)(4) PIECES. 3 MANUFACTURING DHR LOTS PACKED AT BD WERE REVIEWED AND NO ISSUES SIMILAR TO THE ONE STATED BY THE CUSTOMER WERE FOUND. BD LOT NUMBER: MANUFACTURING DATE: SUMMARY OF FINDINGS: 7096551; 27/04/2017; NO RELATED FINDINGS. 7096569; 03/05/2017; NO RELATED FINDINGS. 6221661; 01/06/2016; NO RELATED FINDINGS. DURING THE INVESTIGATION AND REVIEW OF THE DHR¿S OF LOT NUMBERS MENTIONED BY THE CUSTOMER, IT WAS FOUND THAT 4 LOTS OF RAW MATERIAL AA1160155 ONE WAY VALVE WERE USED DURING THE PACKAGING OF THE CATALOG 397019. THE INCOMING INSPECTION RECORDS RELATED TO THE LOT NUMBER OF THE SUPPLIER WERE REVIEWED AND NO ISSUES WERE FOUND RELATED TO DAMAGE OR APPEARANCE ON THE CONNECTOR. INFORMATION OF THIS CLAIM WAS SHARED WITH THE SUPPLIER AS WELL AS THE LOT NUMBERS INVOLVED ON THIS CLAIM, ALSO DEFECTIVE SAMPLE IS IN TRANSIT TO THE SUPPLIER FOR THEIR EVALUATION. WHEN A SAMPLE INVESTIGATION IS COMPLETED, AN ADDITIONAL SUPPLEMENTAL WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE SAMPLES WERE FORWARDED TO FILTERTEK FOR A SUPPLIER INVESTIGATION. THE SUPPLIER PERFORMED BACKFLOW TESTING ON THE USED UNIT AND ONE OF THE VALVES FAILED THE TESTING. THE UNIT WAS DISSECTED AND A THREAD-LIKE SUBSTANCE WAS OBSERVED ADJACENT TO THE SEALING RING. THE SUBSTANCE WAS DETERMINED TO MOST LIKELY HAVE CAUSED THE BACKFLOW ISSUE. EACH OF THE UNUSED UNITS WERE THEN VISUALLY INSPECTED AND NO PHYSICAL OR MECHANICAL DAMAGE TO ANY OF THE UNITS' COMPONENTS WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED ON EACH UNIT AND THE UNITS MET MANUFACTURING STANDARDS. THE UNITS WERE THEN DISSECTED AND THREAD-LIKE SUBSTANCES WERE OBSERVED IN TWO OF THE VALVES AND PARTICULATE WAS OBSERVED ON ANOTHER UNIT. THE PARTICULATE WAS DETERMINED TO HAVE BEEN INTRODUCED DURING THE INSPECTION PROCESS AT THE SUPPLIER FACILITY. A SOURCE FOR THE THREAD-LIKE SUBSTANCES COULD NOT BE IDENTIFIED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. THIS IS THE FIRST TIME THAT WE HAVE THIS KIND OF ISSUE RELATED TO THE CUSTOMER DEFECTIVE CHECK VALVE; HOWEVER, THE SAMPLE HAS NOT BEING EVALUATED AT THIS POINT BECAUSE IT WAS SENT TO THE SUPPLIER TO BE EVALUATED WHICH IS ESSENTIAL TO PERFORM A BETTER INVESTIGATION. QUALITY RECORDS HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES AND NO ISSUES LIKE THIS ARE DETECTED WHICH MEANS PRETTY LOW OCCURRENCE. WE WILL KEEP MONITORING THE MANUFACTURING PROCESS AND IN CASE ANY EMERGING TREND IS DETECTED, FURTHER ACTIONS WILL BE TAKEN IF NECESSARY. THE CATALOG 397019 IT IS A CHECK VALVE CONNECTOR THAT IT IS RECEIVED AS A RAW MATERIAL, THEN IT IS PACKED IN A BLISTER AND PLACED INTO A BOX WITH A QUANTITY OF (B)(4) PIECES. 3 MANUFACTURING DHR LOTS PACKED AT BD WERE REVIEWED AND NO ISSUES SIMILAR TO THE ONE STATED BY THE CUSTOMER WERE FOUND. BD LOT NUMBER: MANUFACTURING DATE: SUMMARY OF FINDINGS: 7096551; 27/04/2017 ; NO RELATED FINDINGS. 7096569; 03/05/2017; NO RELATED FINDINGS. 6221661; 01/06/2016; NO RELATED FINDINGS. DURING THE INVESTIGATION AND REVIEW OF THE DHR¿S OF LOT NUMBERS MENTIONED BY THE CUSTOMER, IT WAS FOUND THAT 4 LOTS OF RAW MATERIAL AA1160155 ONE WAY VALVE WERE USED DURING THE PACKAGING OF THE CATALOG 397019. THE INCOMING INSPECTION RECORDS RELATED TO THE LOT NUMBER OF THE SUPPLIER WERE REVIEWED AND NO ISSUES WERE FOUND RELATED TO DAMAGE OR APPEARANCE ON THE CONNECTOR. INFORMATION OF THIS CLAIM WAS SHARED WITH THE SUPPLIER AS WELL AS THE LOT NUMBERS INVOLVED ON THIS CLAIM, ALSO DEFECTIVE SAMPLE IS IN TRANSIT TO THE SUPPLIER FOR THEIR EVALUATION. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. THE SAMPLES WERE FORWARDED TO FILTERTEK, WHO CONDUCTED AN INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7096569; MEDICAL DEVICE EXPIRATION DATE: 2020-05-31; DEVICE MANUFACTURE DATE: 2017-05-31. MEDICAL DEVICE LOT #: 7096551; MEDICAL DEVICE EXPIRATION DATE: 2020-04-30; DEVICE MANUFACTURE DATE: 2017-05-22. MEDICAL DEVICE LOT #: 6221661; MEDICAL DEVICE EXPIRATION DATE: 2019-09-30; DEVICE MANUFACTURE DATE: 2016-09-27. PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND/OR IS NOT SOLD IN THE U.S. 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¿ ONE-WAY VALVE WAS OPEN ON BOTH ENDS, IT WAS DEFECTIVE AND NOT ONE-WAY. THE PATIENT REQUIRED A STRONGER DRUG TO STABILIZE THEIR STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740223 BD¿ ONE-WAY VALVE ONE WAY VALVE FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention