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

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

Common device name: catheter, intravascular, therapeutic, long-term greater than 30 days.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported by translation of the original complaint description during administration to the patient the tip of the turbo-ject power injectable peripherally inserted central catheter (picc) line is defective at the purple attachment.A replacement picc line was used.They were no clinical consequences to the patient reported.At the time of this report no additional information is available.

Manufacturer Narrative

Investigation - evaluation.The device was not returned for evaluation however, a document review of the complaint history, device history record, documentation, instructions for use (ifu), specifications, and quality control was conducted during the investigation.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.With the current information available, a cause for this specific failure mode is not able to be established at this time.Measures are being investigated to address this failure mode.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Should additional information become available, the file will be updated accordingly.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.

Event Description

Additional information has been requested but no additional information related to the event description has been received as of the date of this submission.

• 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
• MDR Report Key: 7916075
• MDR Text Key: 122004575
• Report Number: 1820334-2018-02804
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00827002561991
• UDI-Public: (01)00827002561991(17)181006(10)7338608
• Combination Product (y/n): N
• PMA/PMN Number: K111244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

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 Expiration Date: 10/06/2018
• Device Model Number: N/A
• Device Catalogue Number: UPICS-4.0-CT-OTW-ST-1110
• Device Lot Number: 7338608
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 11/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1