BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC

    MDR report key: 8472731 · Received April 2, 2019

    Report

    Report Number
    1820334-2019-00826
    Event Type
    Injury
    Date Received
    April 2, 2019
    Date of Event
    February 16, 2019
    Report Date
    August 5, 2019
    Manufacturer
    COOK INC
    Product Code
    FOZ
    UDI-DI
    00827002056763
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. ADDITIONAL INFORMATION: D10 ¿ PRODUCT RECEIVED ON. INVESTIGATION - EVALUATION A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL AND SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE 3FR PICC WAS RETURNED FOR EVALUATION IN A USED AND DAMAGED CONDITION. BIOLOGICAL MATTER WAS PRESENT ON THE DEVICE. THE DISTAL CATHETER TUBING APPEARED TWISTED AND KINKED, LIKELY FROM USE. AT THE PROXIMAL HUB, THERE WAS A SPLIT IN THE CLEAR EXTENSION TUBING WHERE IT ENTERS THE HUB. NO ADDITIONAL SURFACE DAMAGE WAS NOTED. THE EXTENSION TUBING LENGTH FROM THE MANIFOLD TO THE HUB AND THE EXTENSION TUBING OUTER DIAMETER WAS MEASURED AND FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. THE DEVICE¿S EXTENSION TUBING WAS SPLIT AT THE HUB BUT WAS NOT OUT OF SPECIFICATION FOR ANY ATTRIBUTED MEASURED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. ALL TEST ARTICLES MET THE ACCEPTANCE CRITERION AND THEIR TENSILE TEST PEAK LOADS EXCEEDED THE REQUIREMENT. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 9112705 FOUND NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE FAILURE MODE. IT SHOULD BE NOTED THAT NO OTHER COMPLAINTS WERE REPORTED FOR THIS LOT. THERE IS NO EVIDENCE TO SUGGEST THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: HOW SUPPLIED UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. APPROPRIATE MEASURES HAVE BEEN TAKEN TO ADDRESS THIS FAILURE MODE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    IN ADDITIONAL INFORMATION RECEIVED ON 11APR2019, IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED UNDER GENERAL ANESTHESIA. THE HUB WAS "BEING ACCESSED AS USUAL AND THE PARENT NOTED LEAKING AT THE JOINT BETWEEN THE ORANGE END AND THE CLEAR TUBING. CLARIFICATION WAS MADE REGARDING THE "ORANGE CONNECTOR." THE ORANGE END IS THE END HUB. PATIENT DEMOGRAPHICS ARE NOT BEING PROVIDED.

    Description of Event or Problem · 0

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    OCCUPATION: RISK ANALYST. PMA/510(K) #: K100974. 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 A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC WAS USED IN AN UNKNOWN PATIENT DURING AN UNKNOWN PROCEDURE. AS REPORTED BY THE USER THE DEVICE " FRACTURED AT THE DISTAL END AT THE JUNCTION OF THE ORANGE CONNECTOR AND THE CLEAR TUBING." NO PORTION OF THE DEVICE REMAINS IN PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE AND THERE ARE NO REPORTED ADVERSE EVENTS ASSOCIATED WITH THE DEVICE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268301 SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC N/A 9112705 00827002056763

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention