BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER

    MDR report key: 10277676 · Received July 15, 2020

    Report

    Report Number
    9612007-2020-00002
    Event Type
    Injury
    Date Received
    July 15, 2020
    Report Date
    January 15, 2020
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LTD.
    Product Code
    GWM
    PMA / PMN Number
    K040235
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IDENTIFIERS: (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORDS OF REF IP2P, LOT 213478, WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY. A COMPLAINT INVESTIGATION (FAILURE ANALYSIS) AND DETERMINATION OF ROOT CAUSE IS NOT POSSIBLE AS THE COMPLAINT COULD NOT BE VERIFIED DUE TO A PRODUCT SAMPLE WAS NOT RETURNED IN ORDER TO VERIFY THE COMPLAINT. BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA PR 229048 AND NC 20-011 HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(4), DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(4), ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A MEDWATCH WITH UF/IMPORTER REPORT # (B)(4) WAS RECEIVED ON 15JAN2020. IT WAS REPORTED THAT DURING THE USE OF THE IP2P KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER, A (B)(6)-YEAR-OLD PATIENT WAS GIVEN A 10 MG PROPOFOL BOLUS PRIOR TO REPOSITIONING. TWO NURSES BEGAN REPOSITIONING PATIENT ONTO RIGHT SIDE WHEN PATIENT BEGAN VIOLENTLY COUGHING AND THRASHING UPPER BODY AND HEAD, BACK AND FORTH. ADDITIONAL 50 MCG FENTANYL BOLUS WAS GIVEN. A NURSE OBSERVED BLOOD TINGED CEREBROSPINAL FLUID (CSF) POURING ONTO BED AS PATIENT CONTINUED COUGHING. BOTH NURSES IMMEDIATELY POSITIONED PATIENT ONTO BACK AND RAISED HEAD OF BED (HOB) TO 45 DEGREES. WHILE ASSESSING THE PATIENT, FIBEROPTIC PIECE FROM LICOX/CAMINO BOLT DISLODGED AND FELL ONTO PATIENT'S BED. BLOOD TINGED CSF EXPELLED OUT OF BOLT DEVICE. ONE NURSE HELD GLOVED HAND OVER SITE TO STOP CSF WHILE ANOTHER NURSE RAN TO GRAB CAP TO STOP CSF FROM POURING OUT. WRITER NURSE STAYED AT BEDSIDE HOLDING THE PATIENT IN PLACE TO IMMOBILIZE. A STERILE BLUE CAP WAS PLACED OVER THE OPENING BOLT. NEUROSURGERY RESIDENT ON CALL WAS PAGED IMMEDIATELY DURING EVENT TO ASSESS PATIENT AND LICOX/CAMINO. NEUROSURGERY PHYSICIAN RETURNED PAGE AND WAS PROMPTLY AT BEDSIDE. AS PER NEUROSURGERY PHYSICIAN, "KEEP THE STERILE BLUE CAP SCREWED ONTO BOLT PIECE UNTIL FURTHER EVALUATION IN THE MORNING AS WELL AS LEAVE EXTERNAL VENTRICULAR DRAIN (EVD) UNCLAMPED WHEN REPOSITIONING THE PATIENT'. THERE WAS A CONTINUOUS LEAKING AROUND THE BOLT SITE, THE BOLT WAS REMOVED AFTER CONSULTING NEUROSURGERY TEAM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740040 KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER LICOX BOLTS CATHETERS & KITS GWM INTEGRA LIFESCIENCES (IRELAND) LTD. 213478

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR