BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS SYR PSD MICROBORE

    MDR report key: 10411767 · Received August 15, 2020

    Report

    Report Number
    9616066-2020-02412
    Event Type
    Malfunction
    Date Received
    August 15, 2020
    Date of Event
    July 16, 2020
    Report Date
    July 23, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403233906
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: EVALUATION STATEMENT IT WAS REPORTED THAT TUBING WOULD NOT PRIME. RECEIVED FROM THE CUSTOMER IS ONE USED SYRINGE EXTENSION SET MODEL 10014914 LOT 19125380 (WITH ITS PACKAGING POUCH). THE SET WAS VISUALLY INSPECTED FOR KINKS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. NO ANOMALIES WERE OBSERVED ON THE SET DURING INITIAL VISUAL INSPECTION. FUNCTIONAL TESTING WAS PERFORMED BY FILLING A LAB SYRINGE WITH BLUE DYE WATER AND ATTACHING IT TO THE FEMALE LUER PORT ON THE SET ALLOWING FLUID TO FLOW THROUGH THE WHOLE SET BY FLUSH. PRIMING THE SET BY FLUSH WAS UNSUCCESSFUL AND WAS MET WITH AN OCCLUSION. CLOSER INSPECTION UNDER A LAB MICROSCOPE FOUND EXCESSIVE SOLVENT WHERE THE TUBING (P/N 660136) MEETS THE FEMALE LUER (P/N 630-01364). A LAB NEEDLE WAS USED TO PUNCTURE THE EXCESSIVE SOLVENT AND THE SET WAS ABLE TO BE PRIMED AFTER. NO FURTHER TESTING WAS PERFORMED AS THE CUSTOMER¿S REPORT WAS CONFIRMED. EQUIPMENT USED FOR TESTING ON (B)(6)2020: - RAM OPTICAL INSTRUMENTATION/EQ08204/CALIBRATION DUE DATE 5-FEB-2021. DEVICE HISTORY RECORD FOR MODEL 10014914 LOT 19125380 SHOWS THAT THE SET WAS MANUFACTURED ON 4 DECEMBER 2019 WITH A TOTAL OF 12,003 UNITS. THERE WERE NO QN¿S (QUALITY NOTIFICATION) ISSUED DURING THE PRODUCTION BUILD OF THIS LOT FOR THE FAILURE MODE REPORTED. ROOT CAUSE ANALYSIS: THE CUSTOMER¿S REPORT OF TUBING WOULD NOT PRIME WAS CONFIRMED. THE SOURCE OF THE OCCLUSION IS DUE TO EXCESSIVE SOLVENT AT THE ENGAGEMENT BETWEEN THE TUBING AND FEMALE LUER COMPONENT. THE ROOT CAUSE OF THE EXCESSIVE SOLVENT IS A MANUFACTURING ERROR DUE TO EQUIPMENT AND/OR OPERATOR ERROR. INVESTIGATION CONCLUSION: THE CUSTOMER¿S REPORT OF TUBING WOULD NOT PRIME WAS CONFIRMED. FUNCTIONAL TESTING WAS NOT ABLE TO PRIME THE SET AND CLOSER INSPECTION UNDER A LAB MICROSCOPE FOUND EXCESSIVE SOLVENT WHERE TUBING MEETS THE FEMALE LUER. A LAB NEEDLE WAS USED TO PUNCTURE THE EXCESSIVE SOLVENT AND THE SET WAS ABLE TO BE PRIMED AFTER. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS SYR PSD MICROBORE TUBING WOULD NOT PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10014914 BATCH(LOT) NO: 19125380 IT WAS REPORTED THAT TUBING WOULD NOT PRIME. CUSTOMER RESPONSE (ADDITIONAL INFORMATION) (B)(6) -2020: 1. WHAT WERE THE DATES AND TIMES OF THE EVENTS? (B)(6) 2020, MOSTLY AT NIGHT. I DO NOT HAVE SPECIFIC DATES/TIMES. 2. WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE EVENT OR OCCURRED DURING PREPARATION/PRIMING? THESE WERE NOT ATTACHED TO A PATIENT, THE EVENT OCCURRED DURING ATTEMPTING TO PRIME. 3. IF PATIENT INVOLVEMENT; WAS THERE ANY EFFECT ON THE PATIENT FROM THE EVENT? N/A 4. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE EXPLAIN: DELAY IN GETTING FLUIDS HUNG. 5. WAS THE TUBING STILL COILED WITH TAPE IN PLACE DURING PRIMING/FLUSHING? THE TUBING WAS NOT STILL COILED WITH THE PAPER TAPE DURING PRIMING. 6. HOW FAR IN THE BAG IS THE SPIKE? N/A, IT CONNECTS DIRECTLY TO A SYRINGE AND THE SYRINGE WAS FUNCTIONING APPROPRIATELY. 7. WHAT IV BAG IS IN USE? MANUFACTURER, BRAND & SIZE (50ML, 100ML, ETC.) BD SYRINGES, 5ML-30ML 8. WHAT STEPS DO YOU TAKE TO HELP WHEN YOU DO NOT SEE FLOW? MASSAGE TUBING, SQUEEZE INFUSION BAG, OTHER TECHNIQUE? WHICH ONE OF THESE, IF ANY, HELPS THE FLUID FLOW. WE TRIED DIFFERENT SIZES OF SYRINGES, USING FORCE FROM A SOLID SURFACE AGAINST THE PLUNGER OF THE SYRINGE (BENT THE SYRINGE PLUNGER), STRETCHING AND MASSAGING THE TUBING, MASSAGING THE DISC, AND STILL COULD NOT GET THE FLUID TO PASS THROUGH THE DISC PORTION OF THE PRESSURE SENSING DISC TUBING. 9. ARE THE PRODUCTS INVOLVED IN THE EVENT AVAILABLE FOR INVESTIGATIONAL PURPOSES? YES, THOSE THAT I HAVE I WILL BE SENDING TO YOU. ONE OF THE TUBING SETS WAS PLACED IN THE WRONG PACKAGING, SO I AM NOT SURE OF THE LOT # FOR THAT PARTICULAR PACKAGE. I HAVE ASKED OUR STAFF TO CONTINUE TO TURN IN ANY MORE TUBING THAT IS NOT WORKING I HAVE HAD 3 DIFFERENT NURSES DROP OFF PRESSURE SENSING DISC TUBING IN MY OFFICE THE PAST 2 WEEKS BECAUSE THE TUBING WOULD NOT PRIME. I TRIED MYSELF AND YOU CANNOT PRIME THROUGH THE DISC AT ALL EVEN WITH GREAT FORCE. THEY ARE ALL THE SAME PRODUCT NUMBER, BUT I ONLY HAVE THE LOT NUMBER FOR TWO OF THEM.

    Additional Manufacturer Narrative · 1

    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 TUBING WOULD NOT PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10014914, BATCH(LOT) NO: 19125380. IT WAS REPORTED THAT TUBING WOULD NOT PRIME. CUSTOMER RESPONSE (ADDITIONAL INFORMATION) 23-JUL-2020: WHAT WERE THE DATES AND TIMES OF THE EVENTS? 7/15/20 -7/17/20, MOSTLY AT NIGHT. I DO NOT HAVE SPECIFIC DATES/TIMES. WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE EVENT OR OCCURRED DURING PREPARATION/PRIMING? THESE WERE NOT ATTACHED TO A PATIENT, THE EVENT OCCURRED DURING ATTEMPTING TO PRIME. IF PATIENT INVOLVEMENT; WAS THERE ANY EFFECT ON THE PATIENT FROM THE EVENT? N/A. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE EXPLAIN: DELAY IN GETTING FLUIDS HUNG. WAS THE TUBING STILL COILED WITH TAPE IN PLACE DURING PRIMING/FLUSHING? THE TUBING. WAS NOT STILL COILED WITH THE PAPER TAPE DURING PRIMING. HOW FAR IN THE BAG IS THE SPIKE? N/A, IT CONNECTS DIRECTLY TO A SYRINGE AND THE SYRINGE WAS FUNCTIONING APPROPRIATELY. WHAT IV BAG IS IN USE? MANUFACTURER, BRAND & SIZE (50ML, 100ML, ETC.) BD SYRINGES, 5ML-30ML. WHAT STEPS DO YOU TAKE TO HELP WHEN YOU DO NOT SEE FLOW? MASSAGE TUBING, SQUEEZE INFUSION BAG, OTHER TECHNIQUE? WHICH ONE OF THESE, IF ANY, HELPS THE FLUID FLOW. WE TRIED DIFFERENT SIZES OF SYRINGES, USING FORCE FROM A SOLID SURFACE AGAINST THE PLUNGER OF THE SYRINGE (BENT THE SYRINGE PLUNGER), STRETCHING AND MASSAGING THE TUBING, MASSAGING THE DISC, AND STILL COULD NOT GET THE FLUID TO PASS THROUGH THE DISC PORTION OF THE PRESSURE SENSING DISC TUBING. ARE THE PRODUCTS INVOLVED IN THE EVENT AVAILABLE FOR INVESTIGATIONAL PURPOSES? YES, THOSE THAT I HAVE I WILL BE SENDING TO YOU. ONE OF THE TUBING SETS WAS PLACED IN THE WRONG PACKAGING, SO I AM NOT SURE OF THE LOT # FOR THAT PARTICULAR PACKAGE. I HAVE ASKED OUR STAFF TO CONTINUE TO TURN IN ANY MORE TUBING THAT IS NOT WORKING. I HAVE HAD 3 DIFFERENT NURSES DROP OFF PRESSURE SENSING DISC TUBING IN MY OFFICE THE PAST 2 WEEKS BECAUSE THE TUBING WOULD NOT PRIME. I TRIED MYSELF AND YOU CANNOT PRIME THROUGH THE DISC AT ALL EVEN WITH GREAT FORCE. THEY ARE ALL THE SAME PRODUCT NUMBER, BUT I ONLY HAVE THE LOT NUMBER FOR TWO OF THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875973 AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET FPA CAREFUSION 10014914 19125380 10885403233906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200716