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	08/19/2017
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, without any excessive force, the redo single lumen tpn catheter was leaking fluid.The fluid was coming from a break in the line that reportedly occurred in the thinnest portion of the device.No additional procedures or patient adverse events were reported.The circumstances surrounding the handling and usage of the device are not known.The customer has indicated that the device will not be returning for evaluation.
Additional Manufacturer Narrative
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, without any excessive force, the redo single lumen tpn catheter was leaking fluid.The fluid was coming from a break in the line that reportedly occurred in the thinnest portion of the device.No additional procedures or patient adverse events were reported.The circumstances surrounding the handling and usage of the device are not known.The customer has indicated that the device will not be returning for evaluation.Additional information was later received in a response to a follow up request for additional information which confirmed that the patient was (b)(6).Additionally, this device was repaired using the device captured under medical device report #: 1820334-2017-02633.
Additional Manufacturer Narrative
Corrected data: (manufacturer is aware that the customer submitted a report to (b)(6) not fda).Investigation ¿ evaluation.A review of the complaint history, device history record, instructions for use (ifu), specifications, and quality control of the device was conducted during the investigation.No complaint device has been returned for investigation and no photos have been provided for review.A thorough review of the device history record observed no non-conformances that may have contributed to this incident associated with the complaint lot number; 7534106.A search of the manufacturer's database for similar complaints revealed this record to be one (1) of three (3) complaints associated with the complaint lot number; 7534106.The redo single lumen tpn catheter set is shipped with instructions for use: (ifu), c_t_tpn_rev6.Pdf; which clearly state the proper warnings, precautions, and instructions for use with each device.Specifically; ¿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¿.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.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.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Measures have been initiated to correct this issue.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
The international customer reported that, without any excessive force, the redo single lumen tpn catheter was leaking fluid.The fluid was coming from a break in the line that reportedly occurred in the thinnest portion of the device.No additional procedures or patient adverse events were reported.The circumstances surrounding the handling and usage of the device are not known.The customer has indicated that the device will not be returning for evaluation.Additional information was later received in a response to a follow up request for additional information which confirmed that the patient was (b)(6) years old.Additionally, this device was repaired using the device captured under medical device report #: 1820334-2017-02633.After further review of the record, it was determined that according to the customer, the event resulted in an interruption of hydration to the patient.

• 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: 6854704
• Report Number: 1820334-2017-02634
• Device Sequence Number: 18991712
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2017

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-4.0-65-REDO
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 09/21/2017; 11/28/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 10/09/2017; 12/05/2017
• 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