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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
Catalog Number UPICDS-5.0-CT-OTW-ST-1110
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/05/2016
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol_(b)(4), compliant/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
The tip of peel away sheath was found to be torn when the physician tried to insert it.No adverse effect was reported.
 
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Brand Name
TURBO-JECT POWER INJECTABLE
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 Key6877175
MDR Text Key87756918
Report Number1820334-2017-03133
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeKR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 09/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2017
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-ST-1110
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received09/12/2017
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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