BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCEA ASV YELLOW MICROBORE

    MDR report key: 10384361 · Received August 10, 2020

    Report

    Report Number
    9616066-2020-02376
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 17, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403273964
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: 08/03/2020. INVESTIGATION CONCLUSION: IT WAS REPORTED THAT THE TUBING CRACKED AND LEAK. RECEIVED ONE USED PCEA SET MODEL: 30893, LOT: UNKNOWN. THE SET WAS VISUALLY INSPECTED FOR OBVIOUS DAMAGE SUCH AS INCOMPLETE BONDING ENGAGEMENTS, CRACKS, FRACTURES, KINKS, HOLES, AND TEARS IN THE TUBING AND ITS COMPONENTS. A RESIDUAL CLEAR, COLORLESS LIQUID WAS PRESENT WITHIN THE SET. NO ANOMALIES OR EVIDENCE OF DAMAGES (CRACKS) WERE OBSERVED UPON INITIAL VISUAL INSPECTION. FUNCTIONAL TESTING WAS PERFORMED BY CONNECTING A 10ML LAB SYRINGE FILLED WITH BLUE DYE LIQUID TO THE PROXIMAL FEMALE LUER OF THE SET¿S ANTISIPHON VALVE. A 22G NEEDLE WAS CONNECTED TO THE DISTAL MALE LUER. THE SYRINGE PLUNGER WAS DEPRESSED WITH VARYING DEGREES OF SPEED/FORCE AND SMALL DROPLETS WERE OBSERVED AT THE ENGAGEMENT BETWEEN THE TUBING (P/N: 605962-000) AND THE INLET PORT OF THE MALE LUER (P/N: 1001-143-022). THE SET WAS THEN PRESSURE TESTED WHILE SUBMERGED UNDERWATER (PER DIR#: (B)(4) ¿ IV DISPOSABLE LEAK TEST METHOD). AIR PRESSURE WAS INCREMENTALLY INCREASED FROM 5 PSI TO 30 PSI. AT 1 PSI, THE SET LEAKED AT THE PREVIOUSLY NOTED LEAK ALONG THE YELLOW STRIPE ON THE TUBING. FURTHER INSPECTION UNDER MAGNIFICATION REVEALED SOME SOLVENT CHANNELS AT THE EXTERIOR TUBING AND INTERIOR MALE LUER SURFACES THAT SEEMED MORE EVIDENT ALONG THE AREA OF THE YELLOW STRIPE OF THE MICROBORE TUBING. SINCE A LOT NUMBER WAS NOT PROVIDED, IT IS UNKNOWN IF THIS SET IS RECALL-AFFECTED. HOWEVER, BD CONDUCTED A MEDICAL DEVICE RECALL THAT INCLUDES CERTAIN LOTS FOR SET MODEL: 30893. TRACKWISE CAPA: PR 486592 WAS COMPLETED TO ADDRESS THIS ISSUE AND DOCUMENTS THE CORRECTIVE ACTION(S). EQUIPMENT USED (MEASUREMENT AND TESTING PERFORMED ON 17SEP2020). AIR PRESSURE REGULATOR WITH PRESSURE GAUGE, EQ00151, CALIBRATION DUE DATE: 07NOV2020 . OPTICAL RAM-CNC, EQ08204, CALIBRATION DUE DATE: 05FEB2021. A DEVICE HISTORY RECORD COULD NOT BE PERFORMED DUE TO NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER¿S REPORT THAT THE TUBING CRACKED WAS NOT CONFIRMED. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE WAS NOT IDENTIFIED AS NO DAMAGES WERE OBSERVED DURING VISUAL INSPECTION. THE CUSTOMER¿S REPORT THAT THE TUBING LEAKED WAS CONFIRMED. THE ROOT CAUSE WAS INVESTIGATED UNDER CAPA: PR 486592. ALTHOUGH THERE ARE MULTIPLE CONTRIBUTING FACTORS, THE PREDOMINANT ROOT CAUSE IS IMPROPER SOLVENT APPLICATION DUE TO INADEQUATE MAINTENANCE OF THE SOLVENT DISPENSER AND AN IMPROPER HOLDING TIME. THIS CREATES AN INADEQUATE INTERACTION AT THE AFFECTED ENGAGEMENT THAT CAN LEAD TO LEAKS AFTER STERILIZATION. THIS FAILURE WILL BE CONTINUED TO BE MONITORED FOR ANY RISING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PCEA ASV YELLOW MICROBORE TUBING WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 30893-07, BATCH (LOT) NO: UNKNOWN. IT WAS REPORTED THE PCA BUTTON WAS PUSHED AND PARENT FELT WETNESS ON THEIR LEG. RN CHECKED TUBING AND NOTICED THE CRACK.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PCEA ASV YELLOW MICROBORE TUBING WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 30893-07 BATCH(LOT) NO: UNKNOWN. IT WAS REPORTED THE PCA BUTTON WAS PUSHED AND PARENT FELT WETNESS ON THEIR LEG. RN CHECKED TUBING AND NOTICED THE CRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849486 PCEA ASV YELLOW MICROBORE INTRAVASCULAR ADMINSTRATION SET FPA CAREFUSION 30893 UNKNOWN 10885403273964

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200701.| 20200701.| 20200701