BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 8531421 · Received April 19, 2019

    Report

    Report Number
    1820334-2019-00955
    Event Type
    Injury
    Date Received
    April 19, 2019
    Date of Event
    January 2, 2019
    Report Date
    June 12, 2019
    Manufacturer
    COOK INC
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS COMPLETED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORDS, DRAWINGS, INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. THE COMPLAINANT RETURNED ONE DOUBLE LUMEN 4.0FR PICC LINE IN A USED CONDITION. TWO ADAPTERS WERE PRESENT ON BOTH HUBS. AT THE WHITE HUB, IT WAS NOTED THE EXTENSION TUBING WAS PARTIALLY SEPARATED AT THE HUB/TUBING JUNCTION. NO OTHER SURFACE DAMAGE ON THE DEVICE WAS NOTED. THE LENGTH OF EXTENSION TUBING WAS MEASURED FROM THE HUB TO THE MANIFOLD. THE EXTENSION TUBING OUTER DIAMETER WAS ALSO MEASURED. BOTH MEASURED TO BE WITHIN MANUFACTURING SPECIFICATIONS. INVESTIGATORS WERE ABLE TO OBSERVE THE REPORTED FAILURE MODE. THE DEVICE WAS PARTIALLY SEPARATED, BUT IT WAS NOT OUT OF SPECIFICATION FOR ANY OF THE ATTRIBUTES MEASURED. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS COMPLAINT WAS REGISTERED FOR AN UNKNOWN RPN. THE CUSTOMER PROVIDED A DEVICE LOT NUMBER, 9113221, HOWEVER THIS IS NOT A VALID LOT NUMBER. A SEARCH WAS CONDUCTED OF ALL 4.0FR DOUBLE LUMEN PICC LINES SOLD TO THIS CUSTOMER IN THE PAST THREE YEARS, NARROWING THE COMPLAINT LOT NUMBER TO SEVERAL POSSIBILITIES. BASED ON THE SALES DATA AND PROVIDED DESCRIPTION, IT IS LIKELY THE COMPLAINT DEVICE WAS A G34545 UPICDS-4.0-CT-40NT-ABRM-1111. BASED ON THE PROVIDED LOT NUMBER AND SALES DATA, IT IS LIKELY THE COMPLAINT DEVICE LOT NUMBER WAS 9113121 AND THE GIVEN NUMBER HAD A TYPO IN IT. THE DEVICE HISTORY RECORD (DHR) FOR DEVICE LOT 9113121, PICC COMPONENT LOT IC8501029, AND PICC COMPONENT LOT IC8978412 WAS REVIEWED AND FOUND NO RELEVANT NON-CONFORMANCES. A REVIEW OF COMPLAINT HISTORY RECORDS INDICATES THAT THERE ARE NO OTHER REPORTED COMPLAINTS FROM DEVICE LOT 9113121. NO DEVICES FROM DEVICE LOT 9113121 WERE AVAILABLE AT THE NORTH AMERICAN DISTRIBUTION CENTER (NADC) FOR INSPECTION. THERE IS NO INFORMATION REGARDING THE SECUREMENT OF THE DEVICE, CARE AND MAINTENANCE OF DEVICE OR HOW OFTEN THE DEVICE WAS ACCESSED. IT IS NOT KNOWN HOW THE USER(S) USED THE CLAMPS ON THE LINE; CLOSING THE CLAMP TOO CLOSE TO THE HUB COULD POTENTIALLY CAUSE DAMAGE TO THE LINE. IF THE USER PINCHED THE LINE, FOLDING IT IN HALF TO IMPEDE INFUSION WHILE CHANGING OUT MEDICATIONS COULD CAUSE DAMAGE TO THE LINE. THE PATIENT HAD MULTIPLE MEDICATIONS ADMINISTERED THROUGH THE LINE FOR SEVERAL MONTHS THIS COULD POTENTIALLY CONTRIBUTE TO DAMAGE OF PICC LINE. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. MEASURES ARE IN PROGRESS TO ADDRESS THIS FAILURE MODE. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT.

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: PRODUCT INFORMATION CURRENTLY UNAVAILABLE. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN. PMA/510(K): UNKNOWN. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED AN UNSPECIFIED PERIPHERALLY INSERTED CENTRAL CATHETER LINE (PICC) WAS PLACED IN A (B)(6) YEAR OLD FEMALE ON (B)(6) 2019. ON (B)(6) 2019 IT WAS DISCOVERED THE PICC LINE WAS ¿CRACKED¿. THE REPORT STATED ANOTHER LINE WAS ¿REWIRED¿. THE REPORT FURTHER STATES THE PATIENT HAD MULTIPLE INFUSIONS THROUGH THE LINE INCLUDING: ALBUMIN, MILRINONE, AMIODARONE, ESMOLOL, BIVALIRUDIN, HEPARIN, CALCIUM CHLORIDE, DEXMEDETOMIDINE, FUROSEMIDE, IVIG (PRIVIGEN 10%), KETAMINE, MAGNESIUM SULFATE, MIDAZOLAM, ZOFRAN, POTASSIUM CHLORIDE, POTASSIUM PHOSPHATE, NORMAL SALINE INFUSIONS AND BOLUSES, ANTI-THYMOCYTE GLOBULIN, CEFAZOLIN, CEFEPIME, DECADRON, METHYLPREDNISOLONE, FAMOTIDINE, FENTANYL, DILAUDID, GANCICLOVIR, INSULIN, ATIVAN, LYMPHOCYTE IMMUNE GLOBULINE (ATGAM), MYCOPHENOLATE (CELLCEPT), PANTOPRAZOLE, ROCURONIUM, SODIUM BICARBONATE, EPINEPHRINE, TPN AND INTRALIPIDS, AND PROPOFOL. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAVE BEEN REQUESTED BUT ARE UNAVAILABLE AT THIS TIME. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324557 UNKNOWN LJS COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention