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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

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COOK INC TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER Back to Search Results
Catalog Number UPICDS-5.0-CT-OTW-1110
Device Problem Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2016
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
It was reported the catheter tip jumps back into brachiocephalic vein when flushing with saline with 10 cc syringe despite the tip being in the lower 3rd of the superior vena cava.As a result, to assure the catheter tip is placed far enough, 3 of the catheter tips were advanced even further down into the atrium to no avail.According to the physician, this type of event has occurred 8 times.
 
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Brand Name
TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC
Type of Device
LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6872503
MDR Text Key87341097
Report Number1820334-2017-03091
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 09/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUPICDS-5.0-CT-OTW-1110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/12/2017
Initial Date FDA Received09/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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