BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCUDRAIN WITH ANTI-REFLUX VALVE

    MDR report key: 10918011 · Received November 30, 2020

    Report

    Report Number
    2648988-2020-00043
    Event Type
    Death
    Date Received
    November 30, 2020
    Report Date
    November 6, 2020
    Manufacturer
    INTEGRA LIFE SCIENCES CORP
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: UDI: (B)(4). ADDITIONAL COMPLAINT INFORMATION REPORTED THAT THE DEVICE MALFUNCTION DID NOT RESULT IN PATIENT INJURY OR DEATH; NONETHELESS, IT CONTINUES TO REPORT THAT THE PATIENT EVENTUALLY DIED, ¿BUT IT WAS NOT BECAUSE OF THE DRAIN LEAKING.¿ A MEDICAL ASSESSMENT WAS PREPARED BY INTEGRA¿S MEDICAL SAFETY WHICH CONCLUDED THE FOLLOWING: ¿THERE IS NO DATA TO SUGGEST A CAUSAL RELATIONSHIP BETWEEN THE REPORTED PRODUCT PERFORMANCE ISSUE AND PATIENT DEATH. THE REPORTER ALSO STATED THE DEMISE IS NOT A RESULT OF THE PRODUCT MALFUNCTION. THE COMPLAINANT PROVIDED LIMITED INFORMATION ON THE MALFUNCTION. CLARIFICATION ON THE SET-UP OF THE DEVICE AND POTENTIAL CAUSE OF DEATH WAS REQUESTED, WITH NO FURTHER INFORMATION PROVIDED BY THE REPORTER.¿ THE REPORTED LOT¿S DHR WAS REVIEWED AND NO ANOMALY WAS OBSERVED THAT COULD HAVE CAUSED THE REPORTED CONDITION. THE REPORTING CUSTOMER DID NOT PROVIDE A PHOTO TO SHOW WHERE THE LEAKAGE OCCURRED. FROM THE INFORMATION PROVIDED, A LEAKAGE WAS OBSERVED AT THE PATIENT LINE STOPCOCK; NONETHELESS, THE LEAKAGE LOCATION/ORIGIN REMAINS UNKNOWN. FROM COMPLAINT DESCRIPTION IT CAN BE CONCLUDED THAT THE DEVICE WAS IN SERVICE FOR AT LEAST 48 HOURS PRIOR TO OBSERVING THE LEAKAGE. NO FURTHER INVESTIGATION AND ROOT CAUSE DETERMINATION IS POSSIBLE SINCE THE UNIT WAS NOT RECEIVED AT INTEGRA AÑASCO FOR EVALUATION. DURING PRODUCT MANUFACTURING THERE ARE CONTROLS TO AVOID THIS TYPE OF SITUATIONS: PRIOR TO USE, THE PATIENT LINE STOPCOCKS ARE VERIFIED 100% FOR CRACKS AND STRESS MARKS UNDER A MICROSCOPE 3X AS PER TM-1059 (VISUAL INSPECTION OF 4-WAY STOPCOCK). AFTER ASSEMBLY, EACH UNIT IS SUBMITTED TO LEAK AND OCCLUSION TESTS. THEREFORE, LOCAL CONTROLS (INSPECTION AND LEAK TESTS) ENSURE THAT THE STOPCOCKS ARE CRACK AND LEAK FREE.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A NURSE REPORTED AFTER THE ACCUDRAIN WITH ANTI-REFLUX VALVE (PRODUCT ID INS8401) WAS CLAMPED FOR 48 HOURS PRIOR, THE DRAIN LEAKED AT THE STOP COCK CLOSEST TO THE PATIENT, BUT NOT WHERE THE TRANSDUCER WAS ATTACHED. IT WAS REPORTED THAT THE PATIENT DIED, BUT THE PATIENT'S DEATH WAS NOT DUE TO THE DRAIN LEAKING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383113 ACCUDRAIN WITH ANTI-REFLUX VALVE N/A JXG INTEGRA LIFE SCIENCES CORP 4254509

    Patients

    Seq Age Sex Outcome Treatment
    1 Death