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

Catalog Number	UPICS-5.0-CT-NT-1110
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
A picc line was placed on (b)(6) 2016 for treatment.While the patient was at home, the picc line tore apart at the cap level.The patient was given antibiotics.The picc line was changed on (b)(6) 2016.
Additional Manufacturer Narrative
(b)(4).Investigation/evaluation: during the course of the investigation a review of the complaint history, quality control, device history record, instructions for use (ifu), manufacturing instructions, documentation and a visual inspection of the returned product was conducted.The returned product was reviewed and it was confirmed that the extension tubing had partially separated at the hub.The 14mm of the catheter remained, the rest appeared to have been cut off.A connector was returned with the device that was attached to the luer lock connector on the hub.The connector was visually identified as the connector that was supplied in the kit with the product as a microclave neutral displacement connector.It was unknown if the failure mode contributed to the incident of sepsis.Examination of the returned and used product confirmed the presence of hub separation.Review of lot records did not observe any non-conformances that may have contributed to this issue.
Event or Problem Description
A picc line was placed on (b)(6) 2016 for treatment.While the patient was at home, the picc line tore apart at the cap level.The patient was given antibiotics.The picc line was changed on (b)(6) 2016.

• 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: 5666959
• Report Number: 1820334-2016-00321
• Device Sequence Number: 10875494
• Product Code: LJS
• UDI-Device Identifier: 00827002037854
• UDI-Public: (01)00827002037854(17)171020(10)6295989
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2016

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 Catalogue Number: UPICS-5.0-CT-NT-1110
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/24/2016
• Device Age: 6 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2016
• Supplement Report FDA Received Date: 08/25/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention