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

Catalog Number	UPICDS-4.0-CT-NT-1111
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 was reported a turbo-ject® double lumen power-injectable picc (peripherally inserted central catheter) line cracked at the connection of the hub and catheter.This incident was mitigated with a picc rewire.The line was in place for a total of 4 days, secured with a statlock, and used to deliver the following: chemo, lorazepan, mycophenolate and diphenhydramine.To date, additional information regarding the patient and event have not been made available.
Additional Manufacturer Narrative
Additional information: in addition to the initial report, it was reported no defects or abnormalities were observed prior to use.Placement of the device was normal and tension/manipulation of the device did not occur.The device was secured by a stat loc and tegederm.To date, the investigation is still in progress.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
A review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.One device was returned for investigation.A visual examination noted the clear tubing is partially separated from the white fitting.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Quality control specification states all manufactured devices are inspected for dry leak test.A review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.A clinical assessment noted information regarding patient¿s behavior, environment or mobility was not provided and this may have contributed to the unnecessary tension or pulling on the hub.It should be noted the patient was receiving intravenous lorazepam, which is administered for anxiety and/or seizures.There is no further action is required.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
There was no additional information received regarding the event.

• Brand Name: TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC
• 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: 7686198
• Report Number: 1820334-2018-02076
• Device Sequence Number: 634333
• Product Code: LJS
• UDI-Device Identifier: 00827002345140
• UDI-Public: (01)00827002345140(17)200109(10)8499606
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2018

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: 01/09/2020
• Device Catalogue Number: UPICDS-4.0-CT-NT-1111
• Device Lot Number: 8499606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 07/18/2018; 08/22/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/14/2018; 09/19/2018
• 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: 13 MO