MAUDE Adverse Event Report: COOK INC TRIPLE LUMEN SILICONE CENTRAL VENOUS/HYPERALIMENTATION CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Hole In Material (1293)

Patient Problem No Code Available (3191)

Event Date 11/21/2017

Event Type  malfunction  

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 Description

The international customer reported that, during an unknown procedure, the triple lumen silicone central venous/hyperalimentation catheter set was used.The blue lumen of the central venous catheter reportedly had a small hole just below the clamp portion of the device.Blue clamps were subsequently applied proximally and distally to the hole.The patient was then sent for a line exchange.Additional information has been requested from the customer, but none has yet been provided.The complaint device is reportedly unavailable for return and evaluation.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, specifications, and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.However, a documentation evaluation was performed.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.A review of the device history record found no other non-conformances associated with the complaint device lot number (ns7981843).Additionally, a review of the manufacturer's complaint database found one other complaint associated with the complaint device lot number (ns7981843).The device is shipped with instructions for use, which states the proper warnings, precautions, and instructions for use.Based on the provided information, no product returned and the results of our investigation, a definitive root cause could not be determined.However, this failure mode has been escalated per internal processes.

• Brand Name: TRIPLE LUMEN SILICONE CENTRAL VENOUS/HYPERALIMENTATION CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7107584
• MDR Text Key: 95395394
• Report Number: 1820334-2017-04328
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002134904
• UDI-Public: (01)00827002134904(17)200627(10)NS7981843
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-HASTC-1250J-CANADA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention