BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADD-ON BURETTE SS VLV PS BALL VLV

    MDR report key: 12132527 · Received July 7, 2021

    Report

    Report Number
    9616066-2021-51471
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 4, 2021
    Report Date
    August 31, 2021
    Product Code
    FPA
    UDI-DI
    37613203009585
    PMA / PMN Number
    K780130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-05-18. THE FOLLOWING ARE POSSIBLE LOT NUMBERS: D4: MEDICAL DEVICE LOT #: 20106171. D4: MEDICAL DEVICE EXPIRATION DATE: 2023-10-29. H4: DEVICE MANUFACTURE DATE: 2020-10-30. D4: MEDICAL DEVICE LOT #: 20106172. D4: MEDICAL DEVICE EXPIRATION DATE: 2023-10-29. H4: DEVICE MANUFACTURE DATE: 2020-10-30. D4: MEDICAL DEVICE LOT #: 20106173. D4: MEDICAL DEVICE EXPIRATION DATE: 2023-10-30. H4: DEVICE MANUFACTURE DATE: 2020-10-31. D4: MEDICAL DEVICE LOT #: 20106174. D4: MEDICAL DEVICE EXPIRATION DATE: 2023-10-30. H4: DEVICE MANUFACTURE DATE: 2020-10-31. D4: MEDICAL DEVICE LOT #: 20106175. D4: MEDICAL DEVICE EXPIRATION DATE: 2023-10-30. H4: DEVICE MANUFACTURE DATE: 2020-10-31. H6: INVESTIGATION SUMMARY ONE 82115E PRODUCT WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION; HOWEVER A REVIEW OF THE LASER ID FROM THE SMARTSITE COMPONENT CONFIRMED A POSSIBLE LOT NUMBER TO BE EITHER 20106171, 20106172, 20106173, 20106174 OR 20106175. RESIDUAL FLUID WAS PRESENT IN THE PRODUCT. A VISUAL INSPECTION CONFIRMED THE CUSTOMER'S EXPERIENCE AS THE SET WAS RECEIVED IN TWO; THE TUBING WAS RECEIVED SEPARATED FROM BELOW THE FLOAT VALVE OF THE BURETTE. A CLOSER INSPECTION IDENTIFIED RESIDUAL SOLVENT AROUND THE END OF THE TUBING. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. FOLLOWING A REVIEW OF THE MANUFACTURING PROCESS, THEIR ANALYSIS CONFIRMED THAT THE SEPARATION IS MOST LIKELY TO HAVE BEEN CAUSED BY AN INSUFFICIENT AMOUNT OF SOLVENT HAVING BEEN APPLIED TO THE TUBING DURING THE ASSEMBLY PROCESS. THIS IS A MANUALLY PERFORMED ASSEMBLY STEP AND IS LIKELY TO HAVE OCCURRED DUE TO HUMAN ERROR. A REVIEW OF THE PRODUCTION RECORDS FOR LOTS 20106171, 20106172, 20106173, 20106174 AND 20106175 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IN ORDER TO REDUCE THE LIKELIHOOD OF OPERATOR ERROR, THE PRODUCTION PERSONNEL HAVE BEEN INFORMED OF THIS FEEDBACK TO ENSURE THAT THEY ARE FOLLOWING THE CORRECT ASSEMBLY PROCESS. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS AN ISOLATED OCCURRENCE WITH NO FURTHER REPORTS OF THIS NATURE AGAINST THE 82115E PRODUCT OVER THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ADD-ON BURETTE SS VLV PS BALL VLV DISCONNECTED FROM THE DRIP CHAMBER BELOW THE TUBING CONNECTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CONNECTION BETWEEN THE BALL VALVE DRIP CHAMBER AND BECAME DISCONNECTED FROM THE TUBING BELOW THE CHAMBER".

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ADD-ON BURETTE SS VLV PS BALL VLV DISCONNECTED FROM THE DRIP CHAMBER BELOW THE TUBING CONNECTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CONNECTION BETWEEN THE BALL VALVE DRIP CHAMBER AND BECAME DISCONNECTED FROM THE TUBING BELOW THE CHAMBER"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023488 ADD-ON BURETTE SS VLV PS BALL VLV INTRAVASCULAR ADMINISTRATION SET FPA 82115E UNKNOWN 37613203009585

    Patients

    Seq Age Sex Outcome Treatment
    1