BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC

    MDR report key: 11951926 · Received June 7, 2021

    Report

    Report Number
    1820334-2021-01469
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 26, 2021
    Report Date
    April 12, 2022
    Manufacturer
    COOK INC
    Product Code
    FOZ
    UDI-DI
    00827002056763
    PMA / PMN Number
    K100974
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT A COOK SPECTRUM TURBO-JECT POWER-INJECTABLE PICC (UPICS-3.0-CT-NT-ABRM-1110) FROM LOT 13591747 BROKE AT THE JUNCTION BETWEEN THE ORANGE HUB AND EXTENSION TUBE. THE FAILED DEVICE WAS IMPLANTED ON (B)(6) 2021 AND EXPLANTED ON (B)(6) 2021, THEN WAS REPLACED WITH A NEW 3FR SPECTRUM. COOK BECAME AWARE OF THIS EVENT ON (B)(6) 2021 UPON BEING NOTIFIED BY LURIE CHILDREN¿S HOSPITAL (UNITED STATES). REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL, AND INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. HOWEVER, THE CUSTOMER DID SEND A PHOTO OF THE DEVICE. IT APPEARS THE BATWING HUB HAS PARTIALLY SEPARATED FROM THE EXTENSION TUBING. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT AND THE SUBASSEMBLY WORK ORDERS REVEALED NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. BASED ON THE DEVICE MASTER RECORD AND DEVICE HISTORY RECORD, THERE IS NO INDICATION THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. INSTRUCTIONS FOR USE (IFU) DOCUMENT T_UPICABRM_REV2 [COOK SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS WITH MICROPUNCTURE PEEL-AWAY INTRODUCERS] IS PACKAGED WITH THIS DEVICE. THE PRODUCT IFU STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: INTENDED USE: ¿COOK SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETS ARE INTENDED FOR SHORT- OR LONG-TERM USE FOR USE WITH POWER INJECTORS FOR DELIVERY OF CONTRAST IN CT STUDIES. THE MAXIMUM PRESSURE LIMIT SETTING FOR POWER INJECTORS USED WITH THE SPECTRUM TURBO-JECT PICC MAY NO EXCEED 325 PSI AND THE FLOW RATE MAY NOT EXCEED THE MAXIMUM FLOW RATE INDICATED, AS SHOW ON THE FOLLOWING TABLE.¿ WARNINGS: THE SAFE AND EFFECTIVE USE OF SPECTRUM TURBO-JECT PICC LINES WITH POWER INJECTOR PRESSURES SET ABOVE 325 PSI HAS NO BEEN ESTABLISHED. DO NOT POWER INJECT IF MAXIMUM INJECTION RATE CANNOT BE VERIFIED TO MEET LIMIT PRINTED ON CATHETER HUB OR EXTENSION TUBE. TO SAFELY USE SPECTRUM TURBO-JECT PICC LINES WITH A POWER INJECTOR, THE TECHNICIAN/HEALTH CARE PROFESSIONAL MUST VERIFY PRIOR TO USE THAT THE MAXIMUM PRESSURE LIMIT IS SET AT OR BELOW 325 PSI AND THAT THE MAXIMUM FLOW RATE IS AT OR BELOW THAT WHICH IS LISTED ON THE CATHETER. DYNAMIC AND STATIC PRESSURE TEST RESULTS ARE SHOWN IN THE FOLLOWING TABLE.¿ HOW SUPPLIED: ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ A CAPA WAS PREVIOUSLY OPENED TO FURTHER INVESTIGATE THIS FAILURE MODE AND THE PREVIOUS CAPA INVESTIGATION FOUND THAT THIS PRODUCT ISSUE IS RELATED TO DEVICE DESIGN. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE FOR THIS EVENT IS CONSISTENT WITH THE CAPA FINDINGS AND IS RELATED TO INADEQUATE FLEXURAL STRENGTH IN A PREVIOUS HUB DESIGN CHANGE. RISK ASSESSMENT DETERMINED THAT THE RISK IS ACCEPTABLE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL COMMON NAME: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER. ADDITIONAL PRODUCT CODE: LJS. OCCUPATION: IR LEAD TECH; DEPT: INTERVENTIONAL RADIOLOGY. 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 THAT A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC BROKE. THE DEVICE WAS PLACED IN THE PATIENT'S RIGHT VEIN AND WAS USED FOR INFUSION OF MAGNESIUM SULFATE. THE DEVICE WAS HEPARIN LOCKED. AS A RESULT OF THE BREAK, THE DEVICE WAS REMOVED AND REPLACED WITH A NEW 3FR SPECTRUM IN AN ADDITIONAL PROCEDURE. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842818 SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC G05676 13591747 00827002056763

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Male Required Intervention