BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS SYR PSD MICROBORE

    MDR report key: 10532891 · Received September 14, 2020

    Report

    Report Number
    9616066-2020-02772
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    August 9, 2020
    Report Date
    August 25, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403233906
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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: 09/08/2020 INVESTIGATION CONCLUSION THE CUSTOMER REPORTED THAT THE EXTENSION SET LEAKED AT CONNECTION WITH SYRINGE CAUSING MEDS TO LEAK ON THE FLOOR. TWO OF THE THREE REPORTED SYRINGE SETS MODEL 10014914 LOTS REPORTED AS 20075210 AND UNKNOWN WERE NOT RECEIVED FOR EVALUATION. RECEIVED WERE THE FOLLOWING USED SAMPLES- 1)SYRINGE SET MODEL 10014914 LOT UNKNOWN, 2)MAXZERO CONNECTOR MODEL MZ1000-07 LOT REPORTED AS 20037072, 3)NON-BD FILTER SET AND 4)EMPTY NON-BD (COVIDIEN) 2.5ML SYRINGE 0.9% SODIUM CHLORIDE INJECTION LOT 19J1224 EXP 2021-09-30. ALSO RECEIVED WAS THE CUSTOMER'S PRODUCT PROBLEM REPORT FORM WITH DESCRIPTION OF PROBLEM WRITTEN AS "CLAVE LEAKING AT CONNECTION W/ SYRINGE; MEDS LEAKED ON FLOOR. MED = .9% SODIUM CHLORIDE FLUSH SYR 2.5ML FILL". THE SAMPLES WERE RECEIVED ATTACHED TO EACH OTHER: SYRINGE TO MAXZERO. MAXZERO TO SYRINGE SET'S FEMALE LUER. SYRINGE SET'S MALE LUER TO FILTER SET. THE SET SAMPLE WAS INSPECTED FOR KINKS, HOLES/TEARS IN THE TUBING, OR DAMAGES TO THE COMPONENTS. NO ISSUE WAS OBSERVED. THE SYRINGE WAS MANUALLY DETACHED FROM THE MAXZERO. VISUAL INSPECTION OF THE RECENTLY MATED COMPONENT ENDS OBSERVED NO ISSUES. THE SYRINGE WAS FILLED WITH BLUE DYED FLUID AND REATTACHED TO THE MAXZERO. THE FLUID WAS PUSHED THROUGH AND WAS OBSERVED TO FLOW THROUGH AND EXIT AS EXPECTED. NO LEAK WAS OBSERVED. A LAB GAUGE NEEDLE WAS ATTACHED TO THE FILTER SET'S MALE LUER AND BOTH THE SYRINGE AND SYRINGE SET WERE LOADED INTO A LAB SYRINGEMODULE DEVICE. AN INFUSION WAS STARTED AT A RATE OF 2.5ML/HR. THE INFUSION COMPLETED WITH NO LEAK, ALARM, OR ANY ISSUE OBSERVED. FURTHER TESTING WAS PERFORMED ON THE RECEIVED SAMPLES BY PUSHING DOWN ON THE EMPTY SYRINGE WHILE THE SAMPLES WERE SUBMERGED UNDERWATER. NO LEAK OR ANY ISSUE WAS OBSERVED. ALL MATING COMPONENTS WERE MANUALLY DETACHED AND REATTACHED. PUSHING DOWN ON THE EMPTY SYRINGE WHILE THE SAMPLES WERE SUBMERGED UNDERWATER WAS REPEATED. NO LEAK OR ANY ISSUE WAS STILL OBSERVED. THE SYRINGE SET WAS ALSO PRESSURE TESTED UP TO 30PSI WHILE SUBMERGED UNDERWATER (PER IV DISPOSABLES LEAK TEST METHOD DIR 10000360033). NO LEAK OR ANY ISSUE WAS OBSERVED. THE SYRINGE SET'S FEMALE LUER END WAS MEASURED TO BE WITHIN ISO SPECIFICATION. EQUIPMENT USED (TESTING AND MEASUREMENT PERFORMED ON 28SEP2020): - 8110 SYRINGE MODULE/EQ08313 (CALIBRATION/PM DUE DATE 04AUG2021) - 8015 PCU/EQ10291 (CALIBRATION/PM DUE DATE 20MAR2021) - PRESSURE REGULATOR/EQ00138/CALIBRATION DUE DATE 02OCT2020 - FEMALE GO/NO GO GAUGE/EQ08248/CALIBRATION DUE DATE 14SEP2021 THE DEVICE HISTORY RECORD FOR MODEL 10014914 COULD NOT BE CONDUCTED DUE TO NO LOT NUMBER BEING PROVIDED. THE DEVICE HISTORY RECORD FOR MODEL 10014914 LOT 20075210 SHOWS THE SET WAS MANUFACTURED ON 01JUL2020 WITH A TOTAL OF (B)(4) UNITS BUILT. THERE WERE NO RELATED QUALITY NOTIFICATIONS ISSUED DURING THE PRODUCTION BUILD OF THIS SET. THE CUSTOMER'S REPORT THAT THE EXTENSION SET LEAKED AT CONNECTION WITH SYRINGE WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT IDENTIFIED. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS SYR PSD MICROBORE LEAKED MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10014914 BATCH NO: 20075210, 20037072 IT WAS REPORTED THAT EXTENSION SET LEAKED AT CONNECTION WITH SYRINGE CAUSING MEDS TO LEAK ON THE FLOOR.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 20037072, MEDICAL DEVICE EXPIRATION DATE: 2023-07-01, DEVICE MANUFACTURE DATE: 2020-07-01. MEDICAL DEVICE LOT #: 20075210, MEDICAL DEVICE EXPIRATION DATE: 2023-07-01, DEVICE MANUFACTURE DATE:2020-07-01. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS SYR PSD MICROBORE LEAKED MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10014914, BATCH NO: 20075210, 20037072. IT WAS REPORTED THAT EXTENSION SET LEAKED AT CONNECTION WITH SYRINGE CAUSING MEDS TO LEAK ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995000 AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET FPA CAREFUSION 10014914 SEE H.10 10885403233906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MZ1000-07, 20200809| MZ1000-07, 20200809