MAUDE Adverse Event Report: COOK INC REDO SINGLE 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	06/28/2017
Type of Reportable Event	Malfunction
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
International customer reported that a patient received a redo single lumen tpn catheter implanted on (b)(6) 2017 for an unspecified indication.The patient underwent infusion of contrast media during a therapy procedure on (b)(6) 2017.Leakage of contrast fluid from the central venous catheter was observed under x-ray viewing during the procedure.The leak was observed around the device hub and right jugular vein.The customer reports that "no traction or other traumatic action were done." there are no reported adverse patient consequences.No additional procedures or other intervention were required.No further information was provided.The device is reportedly available for evaluation; however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
A review of documentation, device history record, instructions for use, specification and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A 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 device history record review could not be performed as the complaint lot number was not provided.The redo single lumen tpn catheter set is shipped with instructions for use, which clearly state the proper warnings, precautions, and instructions for use with each device.Specifically, the ifu states, ¿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." a definitive root cause could not be determined; however, based on the provided information on the reported device, the actual root cause is ¿inconclusive.¿ we will notify the appropriate personnel and continue to monitor for similar complaints.Measures have been previously initiated to address this issue.Per the quality engineering risk assessment no further action is required.
Additional Manufacturer Narrative
It was erroneously reported that the device lot was unavailable.A review of the device history record did not observe any non-conformances that may have contributed to this incident associated with the complaint lot number 6374318.A thorough review of a complaint history search for similar complaints revealed this record to be the one of two reported complaint(s) associated with the complaint lot number: 6374318.Reference mfr.Report: 1820334-2017-01353 for the related record.
Event or Problem Description
International customer reported that a patient received a redo single lumen tpn catheter implanted on (b)(6) 2017 for an unspecified indication.The patient underwent infusion of contrast media during a therapy procedure on (b)(6) /2017.Leakage of contrast fluid from the central venous catheter was observed under x-ray viewing during the procedure.The leak was observed around the device hub and right jugular vein.The customer reports that "no traction or other traumatic action were done." there are no reported adverse patient consequences.No additional procedures or other intervention were required.No further information was provided.The device is reportedly available for evaluation; however it has not been received by the manufacturer as of the date of this report.The ministry of health form was received from the national competent authority (italy) and contained the following information: "cvc positioned on the (b)(6) 2017.On the (b)(6) 2017 an x-ray to the thorax was performed.At radioscopic examination during the administration of around 1.5ml of mdc through a cvc we observed a spillage of mdc around the catheter both by the insertion at the right jugular vein level and along the catheter¿s subcutaneous communicating tract in correspondence to the thoracic wall.Such samples refer to the fissures of the catheter that however seem continuous".
Additional Manufacturer Narrative
Device evaluation: the visual examination of the returned complaint device noted the tubing had pulled away from the hub.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.

• Brand Name: REDO SINGLE 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: 6725654
• Report Number: 1820334-2017-01758
• Device Sequence Number: 590166
• Product Code: FOZ
• UDI-Device Identifier: 00827002079601
• UDI-Public: (01)00827002079601(17)181204(10)6374318
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/01/2018

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-3.0-65-REDO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 09/13/2017; 10/23/2017; 02/05/2018
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 09/28/2017; 01/09/2018; 03/01/2018
• 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
• Patient Age: 5 MO