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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
Customer reported that a patient received a turbo-ject single lumen peripherally inserted central venous catheter for an unspecified indication.The date of implant was not provided.The customer stated that the " patient awoke to a leaking line this am, no trauma to line but line was cracked at the hub." the device was explanted and replaced with a new device.No further information was provided.The device is not available for evaluation.
Additional Manufacturer Narrative
Investigation: evaluation: a review of complaint history, device history record, instructions for use, quality controls and specification conducted during the investigation.The complaint device has not been returned for investigation and analysis.The turbo-ject single lumen peripherally inserted central venous catheter set is shipped with instructions for use; clearly states the proper warnings, precautions, and instructions for use.Specifically; ¿extreme caution must be used in placement and monitoring.Silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10 ml syringe or larger will reduce the risk of catheter rupture.If lumen flow is impeded, do not force injection or withdrawal of fluids.Catheter size should be as small as the use will allow¿.A thorough review of the device history record revealed one (1) non-conformance for code-416, quantity, incorrect; associated with complaint lot number; 7548326.Appropriate personnel has been notified to resolve this issue.Additionally, a complaint history search for similar complaints revealed this complaint to be the only record associated with complaint lot number.Based on the investigation, 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 definitive root cause could not be determined, however; based on the provided information the actual root cause is deemed to be; ¿inconclusive¿.Per the quality engineering risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.

• 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: 6751044
• Report Number: 1820334-2017-01910
• Device Sequence Number: 652792
• Product Code: LJS
• UDI-Device Identifier: 00827002558830
• UDI-Public: (01)00827002558830(17)181227(10)7548326
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2017

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: N/A
• Device Catalogue Number: UPICS-3.0-CT-NT-1110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1