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	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/05/2017
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
International customer reported that a patient underwent placement of a redo single lumen tpn catheter on an unknown date for total parenteral nutrition (tpn).Customer reported that the outer sheath of the device broke.The device was previously repaired at an unknown time.The site of the break along the catheter length is not known.The circumstances and handling conditions leading up to the event are not known.The device was completely explanted and replaced.It is not known if the device is available for examination.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, 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 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, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Additional Manufacturer Narrative
A review of the complaint history, device history record, instructions for use (ifu), quality control, specifications, and visual inspection of the returned device was conducted during the investigation.One device was returned for investigation.The device was returned in two segments.The distal segment measured 21cm in length and the proximal segment measured 8cm in length.The distal segment was noted to have four places of repair.The point of separation is 4mm below the silicone taper.The points of separation have a jagged appearance.There is no evidence to suggest the finished product was not made to specifications.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 information provided and the results of our investigation, a definitive root cause could not be determined.Measures have been conducted to address this failure mode.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: 6547024
• Report Number: 1820334-2017-00936
• Device Sequence Number: 980782
• Product Code: FOZ
• UDI-Device Identifier: 00827002079038
• UDI-Public: (01)00827002079038(17)190823(10)7154249
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2017

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: C-TPNS-4.0-65-REDO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 08/01/2017; 09/29/2017
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 08/01/2017; 10/13/2017
• 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
• Patient Age: 1 YR
• Patient Weight: 7