BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC

    MDR report key: 6666894 · Received June 26, 2017

    Report

    Report Number
    1820334-2017-01505
    Event Type
    Injury
    Date Received
    June 26, 2017
    Date of Event
    May 1, 2017
    Report Date
    October 31, 2017
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002056763
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    510 (K) : K100974. INVESTIGATION - EVALUATION. A REVIEW OF DEVICE HISTORY RECORD, DRAWING, QUALITY CONTROL DOCUMENTS, COMPLAINT HISTORY , INSTRUCTIONS FOR USE (IFU) AND VISUAL INSPECTION WAS CONDUCTED DURING ON THE RETURNED PRODUCT DURING THE INVESTIGATION THE DEVICE WAS RETURNED IN USED DAMAGED CONDITION. THE CATHETER SHAFT WAS NOT RETURNED. NO VISIBLE DAMAGE WAS NOTED ON THE DEVICE HUB. IT WAS CONFIRMED THAT THERE WAS A SPLIT IN THE EXTENSION TUBING AT THE HUB OF THE MANIFOLD ASSEMBLY PORTION OF THE PICC LINE. A LEAK TEST WAS PERFORMED, CONFIRMING A LEAK THROUGH THIS SPLIT. AS PER THE IFU, THE COOK SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS WITH MICRO PUNCTURE PEEL-AWAY INTRODUCERS LISTS ITS INTENDED USE, INSTRUCTIONS FOR USE, PRECAUTIONS AND WARNINGS FOR OUR PICC SETS. THE CATHETER IS IMPREGNATED WITH THE ANTIMICROBIALS MINOCYCLINE AND RIFAMPIN TO HELP PROVIDE PROTECTION AGAINST CATHETER-RELATED BLOODSTREAM INFECTIONS (CRBSIS). THE COOK SPECTRUM TURBO- JECT PICC IS INDICATED FOR MULTIPLE INJECTIONS OF CONTRAST MEDIA THROUGH A POWER INJECTOR. THE MAXIMUM PRESSURE LIMIT SETTING FOR POWER INJECTORS USED WITH SPECTRUM TURBO-JECT PICC MAY NOT EXCEED 325 PSI AND THE FLOW RATE MAY NOT EXCEED THE MAXIMUM FLOW RATE OF 2ML/SEC. THE DEVICE HISTORY RECORD WAS REVIEWED AND ONE (1) NON-CONFORMANCE WAS IDENTIFIED, WHICH WAS NOT RELATED TO THE REPORTED FAILURE. A THOROUGH REVIEW OF COMPLAINT HISTORY SEARCH REVEALED ONE OTHER COMPLAINT (B)(4) ASSOCIATED TO THE COMPLAINT LOT NUMBER. NO EVIDENCE WAS FOUND TO SUPPORT THAT THE DEVICE WAS MANUFACTURED OUTSIDE OF COOK MEDICAL SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION IT IS NOT CLEAR IF THE LEADING CAUSE TO THIS EVENT MIGHT BE ASSOCIATED WITH INTENSE MOBILIZATION OF THE PATIENT (WHICH COULD DETERMINE AN EVENTUAL CATHETER BREAKAGE), THE MEDICAL PROCEDURE / USER TECHNIQUE, OR A MALFUNCTION OF THE DEVICE. HOWEVER, THE EXACT ROOT CAUSE IS INCONCLUSIVE. WE WILL NOTIFY THE APPROPRIATE PERSONNEL AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. MEASURES HAVE BEEN PREVIOUSLY INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC ON (B)(6) 2017 FOR AN UNSPECIFIED INDICATION. THE PICC LINE WAS OBSERVED BROKEN AND LEAKING ON (B)(6) 2017. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING TO THE EVENT ARE NOT KNOWN. THE DEVICE WAS EXPLANTED ON AN UNKNOWN DATE. THERE IS NO INDICATION THAT A REPLACEMENT DEVICE WAS IMPLANTED. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER SERVICE FOR TRANSITION TO AN IVAD (IMPLANTABLE VENTRICULAR ASSIST DEVICE.) THE CUSTOMER REPORTS THE EVENT CAUSED INCONVENIENCE. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448334 SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A 00827002056763

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention