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	G55883
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: the date of event is estimated to be (b)(6) 2018.(b)(4).Device evaluated by manufacturer - to date, it is unknown if the device will be returned for evaluation.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 leak was observed at the purple hub on a picc line when medication was administered at home.The patient was admitted to the emergency room and a replacement line was placed the following day.As reported, the picc line was used to deliver total parental nutrition (tpn) and a tiny hole was found during the replacement procedure.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.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 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.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
No new event description information to report at this time.

• 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: 7416736
• Report Number: 1820334-2018-00826
• Device Sequence Number: 11003608
• Product Code: LJS
• UDI-Device Identifier: 00827002558830
• UDI-Public: (01)00827002558830(17)190816(10)8147139
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2018

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: Lay User/Patient
• Device Model Number: G55883
• Device Catalogue Number: UPICS-3.0-CT-NT-1110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 07/18/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 13 YR