MAUDE Adverse Event Report: COOK INC TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported that the purple hub of the turbo-ject single lumen peripherally inserted central venous catheter separated from the tubing portion of the device.This ultimately resulted in the need to remove and replace the catheter in an additional line replacement procedure.It reportedly appeared to be a partial separation only, as the device was not completely broken into two pieces.The hub also appeared to be free of cracks, despite the separation from the tubing.The hub was used for infusions of total parenteral nutrition, intralipid's, and lactated ringers solution.Additional information regarding the event has been requested from the customer, but no additional details have been provided at this time.The customer has stated they will not be returning the device.
Event or Problem Description
The customer reported that the purple hub of the turbo-ject single lumen peripherally inserted central venous catheter separated from the tubing portion of the device.This ultimately resulted in the need to remove and replace the catheter in an additional line replacement procedure.It reportedly appeared to be a partial separation only, as the device was not completely broken into two pieces.The hub also appeared to be free of cracks, despite the separation from the tubing.The hub was used for infusions of total parenteral nutrition, intralipids, and lactated ringers solution.Additional information regarding the event has been requested from the customer, but no additional details have been provided at this time.The customer has stated they will not be returning the device.After further review of the record, it was determined that it should be noted that it was clarified to be the purple hub involved in the event and the partial separation appeared to be nearest the end of the hub.
Additional Manufacturer Narrative
A review of the complaint history, device history record, instructions for use (ifu), documentation, specifications, and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record found no other non-conformances associated with the complaint device lot number (6878713).Additionally, a review of the manufacturer's complaint database found no other complaint associated with the complaint device lot number (6878713).Based on the provided information, no product returned and the results of our investigation, a definitive root cause could not be determined.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.

• Brand Name: TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7201997
• Report Number: 1820334-2018-00001
• Device Sequence Number: 1277373
• Product Code: LJS
• UDI-Device Identifier: 00827002558854
• UDI-Public: (01)00827002558854(17)180511(10)6878713
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICS-3.0-CT-80NT-1110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 DA