MAUDE Adverse Event Report: COOK INC COOK TPN DOUBLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a catheter, placed in the external jugular vein of the (b)(6) old female patient on (b)(6) 2016, was leaking fluid from the area near the base of the manifold.The leak was temporarily covered with reinforcing tape on (b)(6) 2016.On (b)(6) 2016 the device was retrieved out of the patient, since therapy was completed at the same time no additional device was placed in the patient.
Additional Manufacturer Narrative
(b)(4).Product has been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported that a catheter, placed in the external jugular vein of the (b)(6) old female patient on (b)(6) 2016, was leaking fluid from the area near the base of the manifold.The leak was temporarily covered with reinforcing tape on (b)(6) 2016.On (b)(6) 2016 the device was retrieved out of the patient.As therapy was completed at the same time.No additional device was placed in the patient.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, specifications, trends and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported 26.4cm of catheter was returned.The catheter was returned with clear tape around the base of the manifold.The device did not leak with the tape in place; the tape was removed to confirm the reported leak.A hole is visibly noted adjacent to the manifold when the catheter is stretched; the same hole is not visible when the catheter is in its relaxed, not stretched condition.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.There is no indication that a design or process related failure mode contributed to this event.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.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.Based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.
Event or Problem Description
It was reported that a catheter, placed in the external jugular vein of the (b)(6) female patient on (b)(6) 2016, was leaking fluid from the area near the base of the manifold.The leak was temporarily covered with reinforcing tape on (b)(6) 2016.On (b)(6) 2016 the device was retrieved out of the patient.As therapy was completed at the same time.No additional device was placed in the patient.

• Brand Name: COOK TPN DOUBLE LUMEN TPN CATHETER SET
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5826130
• Report Number: 1820334-2016-00725
• Device Sequence Number: 342482
• Product Code: FOZ
• UDI-Device Identifier: 00827002018808
• UDI-Public: (01)00827002018808(17)180805(10)6096758
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2016

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-7.0D-65
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/12/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/27/2016
• Supplement Report FDA Received Date: 10/25/2016; 12/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 MO