BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JP PERF DRN SIL FLT 10MM FULL

    MDR report key: 20690582 · Received November 14, 2024

    Report

    Report Number
    1423537-2024-00306
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    October 11, 2024
    Report Date
    December 30, 2024
    Manufacturer
    PR006 PUERTO RICO-ANASCO
    Product Code
    GBX
    UDI-DI
    10192253022377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING FILED FOLLOWING THE SUBMISSION OF THE INITIAL MDR REPORT 1423537-2024-00306 SINCE A SAMPLE WAS RETURNED FOR EVALUATION. A CUSTOMER UNIT WAS RECEIVED, BUT THE RETURNED UNIT WAS A 100CC RESERVOIR, NOT A FLAT DRAIN. THE UNIT WAS NOT RECEIVED IN ITS ORIGINAL PACKAGING AND IT WAS NOT THE PRODUCT DESCRIBED IN THE COMPLAINT. THE DEVICE HISTORY RECORD (DHR) FOR THE FINISHED GOOD WAS REVIEWED AND NO INCIDENT WAS DOCUMENTED THAT COULD HAVE CAUSED THIS TYPE OF NON-CONFORMANCE. NO PRODUCT DISCREPANCIES WERE FOUND DURING THE MANUFACTURING OF BOTH LOTS REFERENCED IN THE DESCRIPTION. THE NON-CONFORMANCE REPORT (NCR) DATA SINCE DECEMBER 2023 TO PRESENT WAS REVIEWED AND NO ISSUES THAT COULD BE RELATED TO THE CONDITION REPORTED WERE FOUND. THE LOT NUMBER 1240323 WAS MANUFACTURED ON MARCH 22,2024 AND THE LOT NUMBER 1240326 WAS MANUFACTURED ON MARCH 27,2024. THIS CATALOG IS FOR SINGLE USE ONLY. ROOT CAUSE FOR THE REPORTED CONCERN CANNOT BE IDENTIFIED SINCE THE RETURNED UNIT WAS NOT THE PRODUCT THAT IS DESCRIBED IN THE REPORTED COMPLAINT. NO ACTIONS TAKEN, SINCE NO EVIDENCE OF A MANUFACTURING ISSUE WAS FOUND.

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS NOT RECEIVED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) FOR THE FINISHED GOOD WAS REVIEWED AND NO INCIDENT WAS DOCUMENTED THAT COULD HAVE CAUSED THIS TYPE OF NON-CONFORMANCE. NO PRODUCT DISCREPANCIES WERE FOUND DURING THE MANUFACTURING OF THESE LOTS. THE NON-CONFORMANCE REPORT (NCR) DATA SINCE OCTOBER 2023 TO PRESENT WAS REVIEWED AND NO ISSUES THAT COULD BE RELATED TO THE CONDITION REPORTED WERE FOUND. THE LOT NUMBER 1240323 WAS MANUFACTURED ON MARCH 22,2024 AND THE LOT NUMBER 1240326 WAS MANUFACTURED ON MARCH 27,2024. THIS CATALOG IS FOR SINGLE USE ONLY. ROOT CAUSE FOR THE REPORTED CONCERN CANNOT BE IDENTIFIED WITH THE AMOUNT OF INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE BEDSIDE NURSE AND HER ORIENTEE WERE DISCONTINUING JP DRAIN FROM PATIENT'S LEFT LEG VEIN GRAFT SITE PER PROTOCOL. NURSE FELT SLIGHT RESISTANCE CONSISTENT WITH TYPICAL JP DRAIN REMOVAL. BULB REMOVED TO ENSURE NO VACUUM PRESENT AND CONTINUED TO REMOVE JP DRAIN. FLEXIBLE CONNECTING TUBING SUDDENLY SHEARED OFF FROM CONNECTION SITE TO DRAINAGE TUBING. DRAINAGE TUBING STAYED INSIDE PATIENT'S VEIN GRAFT SITE, UNABLE TO VISUALIZE. (B)(6) NOTIFIED ME AND I ALSO COULDN'T VISUALIZE THE END OF THE DRAINAGE TUBING STILL INSIDE THE PATIENT'S LEG. SURGEON GAVE A SMALL AMOUNT OF LOCAL ANESTHETIC AT THE SITE WHERE THE DRAIN WAS EXITING THE PATIENT¿S LEG. UITRASOUND WAS USED TO VISUALIZE THE RETAINED PORTION OF THE DRAIN AND A TONSIL CLAMP WAS INSERTED INTO THE EXISTING INCISION AND RETAINED PORTION WAS PULLED OUT FROM THERE. THE CUSTOMER IS UNSURE IF THE DEVICE HAD A LOT NUMBER OF 1240323 OR 1240326.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350629 JP PERF DRN SIL FLT 10MM FULL CATHETER, IRRIGATION GBX PR006 PUERTO RICO-ANASCO SU130-1311 10192253022377

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other