BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO-JECT SINGLE LUMEN POWER-INJECTABLE PICC

    MDR report key: 9775215 · Received March 2, 2020

    Report

    Report Number
    1820334-2020-00526
    Event Type
    Malfunction
    Date Received
    March 2, 2020
    Date of Event
    February 19, 2020
    Report Date
    April 30, 2020
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    10827002345192
    PMA / PMN Number
    K132334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6- ADDITIONAL METHOD CODE: ANALYSIS OF PRODUCTION RECORDS (3331). INVESTIGATION - EVALUATION. IT WAS REPORTED THAT A WIRE GUIDE FROM A TURBO-JECT SINGLE LUMEN POWER-INJECTABLE PICC (UPICS-4.0-CT-NT-1111) FROM LOT 9222430 UNRAVELED. THE CUSTOMER REPORTED THAT SOMETHING FELT WRONG DURING ADVANCEMENT, SO THE WIRE GUIDE WAS ATTEMPTED TO BE WITHDRAWN THROUGH THE NEEDLE. HOWEVER, THE WIRE GUIDE ELONGATED. THE USER WITHDREW THE NEEDLE, BUT THE ELONGATED WIRE GUIDE DID NOT COME WITH THE NEEDLE. THE WIRE WAS ABLE TO BE REMOVED CAREFULLY AND A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. COOK BECAME AWARE OF THIS EVENT ON 20FEB2020 UPON BEING NOTIFIED BY THISTED SYGEHUS NORD. THE PATIENT REPORTEDLY EXPERIENCED NO ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI) AND QUALITY CONTROL, AS WELL AS A VISUAL INSPECTION OF THE RETURNED USED DEVICE AND UNUSED PRODUCT, WAS CONDUCTED DURING THE INVESTIGATION. ONE USED AND FOUR UNOPENED UPIC SETS WERE RETURNED TO COOK FOR EVALUATION. UPON VISUAL INSPECTION, THE WIRE GUIDE FROM THE USED SET WAS FOUND TO BE IN A BROKEN AND ELONGATED STATE INSIDE OF THE NEEDLE. COOK HAS CONCLUDED THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) FOUND THAT SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. A REVIEW OF THE DESIGN HISTORY FILE FOUND THAT THIS DEVICE IS BOTH SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT (9222430) AND THE RELATED WIRE GUIDE SUB-ASSEMBLY LOT REVEALED ONE RELATED NON-CONFORMANCE FOR BROKEN SOLDER IN WHICH TWO DEVICES WERE SCRAPPED. A DATABASE SEARCH FOUND ONE OTHER EVENT ASSOCIATED WITH THE REPORTED DEVICE LOT THAT INTERNALLY ADDRESSES OFFSET COILS FOUND IN ONE OF THE RETURNED UNOPENED DEVICES. GIVEN THIS INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. INSTRUCTIONS FOR USE (IFU) DOCUMENT 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: PRECAUTIONS: STANDARD TECHNIQUES FOR PLACEMENT OF VASCULAR ACCESS SHEATHS, CATHETERS AND WIRE GUIDE SHOULD BE EMPLOYED. INSTRUCTIONS FOR USE: 7. WITHDRAW THE NEEDLE, LEAVING WIRE GUIDE IN PLACE. HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, EVALUATION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE WAS ESTABLISHED AS A COMPONENT FAILURE UNRELATED TO A MANUFACTURING OR DESIGN DEFICIENCY. THE COIL COULD HAVE CAUGHT ON THE SHARP DISTAL TIP OF THE NEEDLE, BUT THIS CANNOT BE CONFIRMED. WITHDRAWING THE WIRE GUIDE THROUGH THE NEEDLE LIKELY CONTRIBUTED TO ADDITIONAL DAMAGE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING 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 PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION: UNKNOWN. 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 THE GUIDEWIRE INCLUDED WITH A TURBO-JECT SINGLE LUMEN POWER-INJECTABLE PICC HAD ELONGATED UPON WITHDRAWAL FROM THE NEEDLE. THE PICC LINE WAS INSERTED INTO AN (B)(6) YEAR OLD FEMALE PATIENT ON (B)(6) 2020. DURING INSERTION OF THE GUIDEWIRE INTO THE NEEDLE, THE OPERATOR OF THE DEVICE "FEELS, THAT SOMETHING IS WRONG" AND TRIED TO WITHDRAW THE GUIDE WIRE. UPON WITHDRAWAL, THE OPERATOR SAW THE "THE GUIDE-WIRE ISN'T AS IT SHOULD BE". SPECIFICALLY, "IT WAS AT LEAST 3 TIMES AS LONG AS USUAL AND LOOKED LIKE A VERY THIN THREAD". THE GUIDEWIRE COULDN'T BE WITHDRAWN THROUGH THE NEEDLE. ONCE THE NEEDLE WAS WITHDRAWN, THE REST OF THE GUIDE-WIRE WAS ABLE TO BE REMOVED. THE SOFT END WAS INTACT, HANGING "TO THE END OF THE VERY THIN THREAD", SO NOTHING WAS LEFT IN THE BODY. ANOTHER NEEDLE AND GUIDE-WIRE WAS USED TO COMPLETE THE PROCEDURE, AND THE SECOND PICC LINE WAS INSERTED "A LITTLE MORE PROXIMAL" WITH NO ISSUES. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239476 TURBO-JECT SINGLE LUMEN POWER-INJECTABLE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A 9222430 10827002345192

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR