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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC TURBO-JECT POWER INJECTABLE; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
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COOK INC TURBO-JECT POWER INJECTABLE; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER Back to Search Results
Model Number G56194
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/04/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap(b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
The customer reported that they were having difficulties pulling the wire through the double-lumen picc line, even after flushing.There were no injuries or additional procedures.
 
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Brand Name
TURBO-JECT POWER INJECTABLE
Common Device Name
LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key6868783
Report Number1820334-2017-03024
Device Sequence Number1182184
Product Code LJS
UDI-Device Identifier00827002561946
UDI-Public(01)00827002561946(17)170707(10)6014512
Combination Product (Y/N)N
Initial Reporter CountryUK
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/15/2017
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
Operator of Device Health Professional
Device Model NumberG56194
Device Catalogue NumberUPICDS-5.0-CT-OTW-ST-1110
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/12/2017
Initial Report FDA Received Date09/15/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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