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

Model Number	G55887
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the initial reporter, the device will not be returned.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It has been reported by the customer that a turbo-ject triple lumen peripherally inserted central venous catheter set was placed on (b)(6) 2018 in the left upper limb of the patient.After placement of the device it was noticed on (b)(6) 2018 that leaking was observed in two of the lumens.The device was then removed and replaced.Reported pre-existing condition included a hepatic abscess.Additional information regarding the event have been requested.A response has not been provided by the customer at the time of this report.
Additional Manufacturer Narrative
Device evaluation: the complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.Investigation: a document-based investigation reviewed the following: complaint history, device history record, drawing, instructions for use, manufacturing instructions, and quality control specifications a review of the current versions governing the manufacturing and quality controls was done.This review found that current process and quality inspection checks are in place to ensure the functionally and device integrity prior to shipment.No specific issue with this documentation that may have contributed to this failure mode was found, and the complaint devices were found to be manufactured within specification.A review of the device history record of the finished product and subassembly show no nonconforming events.A complaint history search revealed that there were no other reported complaints for this lot number.A review of the products instruction for use provides information for end users related to this failure mode.Conclusion: based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.Per the [quality engineering] risk assessment, no further action is required.We have notified the appropriate personnel of this event.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
No new event description information to report at this time.

• Brand Name: TURBO-JECT TRIPLE 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: 8248590
• Report Number: 1820334-2019-00020
• Device Sequence Number: 1593562
• Product Code: LJS
• UDI-Device Identifier: 00827002558878
• UDI-Public: (01)00827002558878(17)200323(10)8690087
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2020
• Device Model Number: G55887
• Device Catalogue Number: UPICTS-6.0-CT-NT-1110
• Device Lot Number: 8690087
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 03/01/2019
• 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: 87 YR