BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60 IN ULTRA MINIBORE EXTENSION SET

    MDR report key: 10193091 · Received June 24, 2020

    Report

    Report Number
    9616066-2020-02004
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    April 16, 2020
    Report Date
    June 4, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403236242
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: A.2. DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. A.2. AGE AT TIME OF EVENT: 3. A.2. AGE UNITS (PATIENT): YEARS. A.3. SEX: MALE. H.3. DEVICE EVALUATED BY MFG?: YES. H.3. REASON DEVICE NOT EVALUATED: OTHER H.3. REASON DEVICE NOT EVAL: SEE H.10. H.6. INVESTIGATION SUMMARY: IT WAS REPORTED BY THE CUSTOMER THAT THE LINE APPEARED TO BE LEAKING WHERE THE LINE CONNECTS TO THE SYRINGE. RECEIVED FROM THE CUSTOMER IS ONE USED EXTENSION SET MODEL ME2017 LOT UNKNOWN. SET WAS RECEIVED WITH TRACES OF MEDICATION IN THE TUBING. THE SET WAS VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. VISUAL INSPECTION FOUND A CRACK IN THE FEMALE LUER WALL (P/N 1024-085-043). NO TOOL MARKS OR SIGNS OF OVER TORQUE WERE OBSERVED. A LAB SYRINGE FILLED WITH BLUE DYE WATER WAS ATTACHED TO THE SET FOR A PRIMING TEST. THE SET LEAKED FROM THE CRACKED FEMALE LUER. NO LEAKS WERE OBSERVED ANYWHERE ELSE THROUGHOUT THE SET. THE FEMALE LUER CAVITY NUMBER IS 54B. DEVICE HISTORY RECORD FOR MODEL ME2017 COULD NOT BE PERFORMED DUE TO NO LOT NUMBER BEING PROVIDED BY CUSTOMER. ROOT CAUSE ANALYSIS: THE CUSTOMER¿S REPORT OF A LEAK WHERE THE LINE CONNECTS TO THE SYRINGE WAS CONFIRMED TO BE A FEMALE LUER CRACK. THE ROOT CAUSE OF THE LUER DAMAGE COULD NOT BE DEFINITIVELY DETERMINED. INVESTIGATION CONCLUSION: THE CUSTOMER¿S REPORT OF A LEAK WHERE THE LINE CONNECTS TO THE SYRINGE WAS CONFIRMED TO BE A FEMALE LUER CRACK. VISUAL INSPECTION FOUND THAT THE FEMALE LUER HAD A LATERAL CRACK. CLOSER INSPECTION UNDER A LAB MICROSCOPE OBSERVED NO TOOL MARKS OR SIGNS OF OVER TORQUE. PREVIOUS INVESTIGATIONS HAVE SHOWN THAT STRESS AND CRACKS MAY RESULT FROM OVERTIGHTENING ON THE FEMALE LUER. IN ADDITION, PREVIOUS SIMILAR INVESTIGATIONS HAVE FOUND THAT IF THE APPLICATION OF ALCOHOL WAS NOT ALLOWED PROPER TIME TO DRY WHEN MATING COMPONENTS, IT COULD CREATE A BOND RESULTING IN DIFFICULTIES DURING DISCONNECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 60 IN ULTRA MINIBORE EXTENSION SET LEAKED AND THE PATIENT DID NOT RECEIVE FULL DOSE OF MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: ME2017 BATCH NO.: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT THE LINE APPEARED TO BE LEAKING WHERE THE LINE CONNECTS TO THE SYRINGE. ADDITIONAL INFO RCVD: UPON FIRST ASSESSMENT, PT'S DEXMEDETOMIDINE LINE APPEARED TO BE LEAKING WHERE THE LINE CONNECTS TO THE SYRINGE. UPON FURTHER INSPECTION, THERE WAS A MODERATE SIZED PUDDLE NEXT TO THE BED WHICH WAS CLEARLY DEXMEDETOMIDINE AND THE PATIENT WAS REPORTED TO HAVE BEEN VERY UNCOMFORTABLE ALL NIGHT AND WAS VISIBLY AGITATED UPON FIRST ASSESSMENT. APPEARS THAT PT DID NOT RECEIVE FULL DOSE OF MEDICATION FOR SEVERAL HOURS. LINE WAS TIGHTLY CONNECTED TO SYRINGE BUT STILL LEAKING. SYRINGE AND LINE REPLACED AND SAVED. PT RESTING COMFORTABLY AT THE TIME OF THIS NOTE.

    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 60 IN ULTRA MINIBORE EXTENSION SET LEAKED AND THE PATIENT DID NOT RECEIVE FULL DOSE OF MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: ME2017, BATCH NO.: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT THE LINE APPEARED TO BE LEAKING WHERE THE LINE CONNECTS TO THE SYRINGE. ADDITIONAL INFO RCVD: UPON FIRST ASSESSMENT, PT'S DEXMEDETOMIDINE LINE APPEARED TO BE LEAKING WHERE THE LINE CONNECTS TO THE SYRINGE. UPON FURTHER INSPECTION, THERE WAS A MODERATE SIZED PUDDLE NEXT TO THE BED WHICH WAS CLEARLY DEXMEDETOMIDINE AND THE PATIENT WAS REPORTED TO HAVE BEEN VERY UNCOMFORTABLE ALL NIGHT AND WAS VISIBLY AGITATED UPON FIRST ASSESSMENT. APPEARS THAT PT DID NOT RECEIVE FULL DOSE OF MEDICATION FOR SEVERAL HOURS. LINE WAS TIGHTLY CONNECTED TO SYRINGE BUT STILL LEAKING. SYRINGE AND LINE REPLACED AND SAVED. PT RESTING COMFORTABLY AT THE TIME OF THIS NOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656887 60 IN ULTRA MINIBORE EXTENSION SET SET, EXTENSION, INTRAVASCULAR FPA CAREFUSION ME2017 UNKNOWN 10885403236242

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other 20200416