MAUDE Adverse Event Report: COOK INC REDO DOUBLE 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	05/03/2017
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 returned at an unspecified time following initial implant for a catheter exchange due to a hole found in the line (1820334-2017-01283.) the physician exchanged the catheter and observed a similar hole on the replacement device (1820334-2017-01266.) there are no reported adverse patient consequences related to this event.No unintended section of the device remained within the patient's body.The device was received by the manufacturer for evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), specifications, and a visual inspection of the returned device was conducted during the investigation.The inspection of the returned device confirmed the presence of leaks in the large lumens.Under magnification, two holes were noted in the material.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there was one other reported complaint for this lot number.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.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: REDO 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: 6597783
• Report Number: 1820334-2017-01266
• Device Sequence Number: 16296864
• Product Code: FOZ
• UDI-Device Identifier: 00827002294646
• UDI-Public: (01)00827002294646(17)200214(10)7432980
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2017

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-9.0D-90-REDO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 08/16/2017
• Patient Sequence Number: 1