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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2017
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
The international customer reported that the redo single lumen tpn catheter broke in the thinnest portion of the device.The circumstances surrounding the handling and usage of the device are not known.Additional information has been requested from the customer.The product is reportedly available for return; however, as of the date of this report, no device has yet been received 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 were conducted during the investigation.The visual inspection of the returned device confirmed that the catheter tubing had come loose from the hub portion of the device.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 were five other reported complaints 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 are being conducted to address this failure mode.The quality engineering risk assessment for this failure mode was reviewed and it was determined that risk mitigation activities are being investigated.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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: 6993026
• Report Number: 1820334-2017-03716
• Device Sequence Number: 11014518
• Product Code: FOZ
• UDI-Device Identifier: 00827002079038
• UDI-Public: (01)00827002079038(17)200119(10)7534106
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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-4.0-65-REDO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR