MAUDE Adverse Event Report: COOK INC TURBO-JECT DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER TRAY; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	G49169
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.(b)(4).
Event or Problem Description
It was reported the patient experienced a problem with her upicdsy-5.0-ct-nt.One lumen was still working but the other lumen was not flushing correctly and could not be used for drawing blood.Additional information received identified attempts using heparin were able to get the second lumen working "some of the time".Subsequently, the purple lumen (patient is not sure if this is the same lumen that could not draw blood before) began pulling air "indicating that it was cracked".Additionally, when clamped and flushed, saline sprayed out where the tubing connects to the purple hub.The patient did require an additional picc placement procedure due to this occurrence.The patient is frustrated by the constant need for replacement.She is also upset that after so many replacements, future pick placements will likely need to be placed in her neck due to all of the replacements.Reference mfr.Reports: 1820334-2017-03085 & 1820334-2017-03086.

• Brand Name: TURBO-JECT DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER TRAY
• 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: 6877189
• Report Number: 1820334-2017-03087
• Device Sequence Number: 1183389
• Product Code: LJS
• UDI-Device Identifier: 00827002491694
• UDI-Public: (01)00827002491694(17)180731(10)6219661
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/18/2017

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: G49169
• Device Catalogue Number: UPICDSY-5.0-CT-NT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/19/2017
• 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