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

Model Number	N/A
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported there was a fissure in the tubing of the peripherally inserted central catheter ( picc) line.The line was discovered to be cracked when getting a blood sample, the presence of air was noted when aspirating.An additional procedure was required to replace the picc line.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation : a review of the device history record, complaint history, trends, quality control, and visual inspection of the returned device were conducted during the investigation.A visual examination of the returned device noted the clear tubing was partially severed from the purple hub.A document based investigation evaluation was also performed.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.Based on the provided information and results of the investigation a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.

• Brand Name: TURBO-JECT STANDARD POWER INJECTABLE PICC LINE 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: 6192637
• Report Number: 1820334-2016-01543
• Device Sequence Number: 976266
• Product Code: LJS
• UDI-Device Identifier: 00827002037779
• UDI-Public: (01)00827002037779(17)180504(10)6949064
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICS-4.0-CT-NT-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 07/14/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention