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	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/02/2017
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
Patient had a turbo-ject single lumen peripherally inserted central venous catheter implanted on (b)(6) 2016 for administration of home based total parenteral nutrition (tpn).The customer reported that the patients' mother connected the patient for tpn treatment.Wetness was observed on the patients' arm one hour after starting tpn treatment.A split at the hub was observed as the source of the wetness.The patient was returned to the hospital and underwent device explant and a tunneled catheterization on (b)(6) 2017.No further information was provided.The device is not available for evaluation.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of complaint history, device history record, instructions for use, specifications and quality control data was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed.Photographs provided by the customer were examined and show a "3 fr upic catheter" with what appears to be a split at the junction of the manifold and at the hub of the device.The split is from an unknown origin.No assignable cause can be determined or attributed from review of the photos; however, based on the client provided photo we can confirm as best as possible, the device is indeed a "3fr single lumen catheter" and that this "hub-split" does not appear to be from any surgical instrumentation or other foreign object.It is most likely attributable to "handling" or "repeated flexing" by medical personnel.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.The device is shipped with instructions for use that clearly states the proper warnings, precautions and instructions for use.Specifically, "extreme caution must be used in placement and monitoring of catheters.Do not power inject if maximum injection rate cannot be verified to meet limit printed on catheter hub or extension tube.If lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Catheter size should be as small as the use will allow." based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.Measures have been initiated to address this failure mode.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: 6536487
• Report Number: 1820334-2017-00831
• Device Sequence Number: 884975
• Product Code: LJS
• UDI-Device Identifier: 00827002558830
• UDI-Public: (01)00827002558830(17)180929(10)7312386
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2017

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: 04/03/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 08/10/2017
• 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