BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC

    MDR report key: 7275359 · Received February 15, 2018

    Report

    Report Number
    1820334-2018-00330
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    December 16, 2017
    Report Date
    April 13, 2018
    Manufacturer
    COOK INC
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, DRAWING, INSTRUCTION FOR USE(IFU), MANUFACTURE INSTRUCTIONS, QUALITY CONTROL DATA , SPECIFICATIONS, AND VISUAL INSPECTION/DIMENSIONAL VERIFICATION OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE DEVICE WAS RETURNED. A TEAR IN THE EXTENSION TUBING WAS NOTED AT THE DISTAL END OF THE ORANGE HUB. EVIDENCE OF BIO-MATTER WAS NOTED ON THE INTERIOR OF THE DEVICE, INDICATING IT WAS LIKELY USED.¿ THE LENGTH, INNER DIAMETER, AND OUTER DIAMETER OF THE EXTENSION TUBING ALL PASSED DIMENSIONAL VERIFICATION. ALTHOUGH THE DEVICE PASSED DIMENSIONAL TESTING, BECAUSE THE LOT NUMBER COULD NOT BE PROVIDED, IT CANNOT BE DETERMINED WHETHER THIS DEVICE WAS MANUFACTURED TO SPECIFICATION. HOWEVER, THE DEVICE MASTER RECORD SHOWS NO INDICATION OF ANY NOTABLE GAPS IN THE MANUFACTURING PROCESS. A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. BECAUSE THE LOT NUMBER FOR THIS DEVICE COULD NOT BE PROVIDED, THE DEVICE HISTORY RECORDS FOR THE UPICS-3.0-CT-NT-ABRM-1110 SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC SET AND ITS SUB-ASSEMBLY COMPONENTS COULD NOT BE REVIEWED. ALTHOUGH THE FOUR REPORTED INCIDENTS OCCURRED WITHIN A MONTH OF EACH OTHER AT THE SAME USER FACILITY, IT CANNOT BE CONFIRMED WHETHER EACH OF THESE FAILURES ORIGINATED FROM THE SAME LOT NUMBER, OR IF OTHER FAILURES IN OUR COMPLAINT MANAGEMENT SYSTEM SHARE ANY OF THE SAME LOT NUMBERS. BASED ON THE INFORMATION PROVIDED, THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE PROPER PERSONNEL ABOUT THIS EVENT. THIS FAILURE MODE HAS BEEN ESCALATED PER INTERNAL PROCESSES. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

    THE CUSTOMER REPORTED THAT THE SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) FAILED AT THE JUNCTION BETWEEN THE CATHETER AND THE HUB PORTION OF THE DEVICE. THE DEVICE WAS PLACED IN A PEDIATRIC PATIENT, AND THE FAILURE REPORTEDLY OCCURRED ON (B)(6) 2017. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN MADE AVAILABLE. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN; AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE A TOTAL OF 4 LINES THAT HAD ISSUES (ALL WITH SAME PART NUMBER). IT WAS NOTED THAT AT LEAST TWO OF THE PICC LINES HAD FRACTURED AND THAT TWO OF THE LINE FAILURES OCCURRED IN THE SAME PATIENT. IT COULD NOT BE DETERMINED IF THIS WAS ONE OF THE TWO EVENTS THAT OCCURRED ON THE SAME PATIENT. PLEASE REFERENCE MFR. REPORT #S: 1820334-2018-00328, 1820334-2018-00362 AND 1820334-2018-00329.

    Additional Manufacturer Narrative · 1

    PMA / 510K #: K100974. (B)(4). 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

    THE CUSTOMER REPORTED THAT THE SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) FAILED AT THE JUNCTION BETWEEN THE CATHETER AND THE HUB PORTION OF THE DEVICE. THE DEVICE WAS PLACED IN A PEDIATRIC PATIENT, AND THE FAILURE REPORTEDLY OCCURRED ON (B)(6) 2017. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN MADE AVAILABLE. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN; AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117245 SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1