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 Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/04/2018
Type of Reportable Event	Malfunction
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
The international customer reported that the turbo-ject single lumen peripherally inserted central venous catheter leaked at the junction of the purple hub and the clear tubing on the distal end of the device.The picc line was utilized at least weekly for infusions of blood products and chemotherapy, as well as blood draws.The product problem occurred approximately 180 days after initial placement and necessitated the use of additional anesthetic and the placement of a new device in an additional procedure.The complaint device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Event or Problem Description
No additional information or changes at this time.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), trends, quality control, and visual inspection of the returned device was conducted during the investigation.The device was returned and the reported issue confirmed.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.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 was one other reported complaint for this lot number.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time, however appropriate measures have been initiated to address this failure mode.

• 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: 7348464
• Report Number: 1820334-2018-00771
• Device Sequence Number: 1556384
• Product Code: LJS
• UDI-Device Identifier: 00827002558830
• UDI-Public: (01)00827002558830(17)190120(10)7606720
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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-NT-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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: 5 YR
• Patient Weight: 25