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	Hole In Material (1293)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2017
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
It was reported by the international customer that, when placing the redo single lumen tpn (total parenteral nutrition) catheter, a hole was noticed proximal to the suture area of the device.The customer further reported that the issue did not cause or contribute to the need for additional procedures, and no patient adverse effects were reported.The product is reportedly returning; however, as of the date of this report, no device has been received for evaluation.
Additional Manufacturer Narrative
Additional information: device evaluated by mfr.Investigation - evaluation: a review of documentation, manufacturing instructions, specifications, drawings, device history record, and quality control data and visual inspection and functional testing of the returned device was conducted during the investigation.One device was returned for investigation.A leak test was conducted and the device was found to leak.Upon closer observation, the catheter was found to leak around and near the repair kit sight.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.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the provided information, inspection of returned product, and the investigation results, a definitive root cause cannot be determined at this time; however, measures have been initiated to address this failure mode.The appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6866182
• Report Number: 1820334-2017-03220
• Device Sequence Number: 10967673
• Product Code: FOZ
• UDI-Device Identifier: 00827002079335
• UDI-Public: (01)00827002079335(17)191206(10)7436857
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-6.5-90-REDO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1