MAUDE Adverse Event Report: COOK INC COOK TPN TRIPLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	C-TPNS-8.0T-90
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight - (b)(6) grams.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a tpn triple lumen catheter lcvc line snapped at the proximal end inside a patient.This patient had norovirus.As reported, this could have been caused by movement.The line was removed and replaced.To date, additional patient and event information has not been made available.
Additional Manufacturer Narrative
A review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.No issues were found related to the reported complaint.One device was returned for investigation.A visual examination noted that the device is heavily soiled with bio matter.There was no visible breakage in the returned portion of the catheter.The instructions for use (ifu) state the catheter may then be trimmed to proper length and flushed with heparinized saline.Due to the device being exposed to the norovirus, a leak test was not performed.A document-based investigation was performed.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 could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.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.
Event or Problem Description
No additional information has been reported since the submission of the initial report on 05/10/2018.

• Brand Name: COOK TPN TRIPLE 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: 7501922
• Report Number: 1820334-2018-01406
• Device Sequence Number: 217975
• Product Code: FOZ
• UDI-Device Identifier: 00827002033191
• UDI-Public: (01)00827002033191(17)200808(10)8073697
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2020
• Device Catalogue Number: C-TPNS-8.0T-90
• Device Lot Number: 8073697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 08/08/2018
• 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: 24 MO