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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Surgical procedure, additional (2564); No Code Available (3191)

Event Date 06/05/2015

Event Type  Injury  

Event Description

Approximately 1 week before the separation, the complaint catheter was placed in a patient.On (b)(6) 2015, the catheter got separated at the connection part between tube and hub.It was replaced with another tpn double lumen tpn catheter set.No additional information has been provided.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

Udi # not available on this device.(b)(4).Event evaluation: a dimensional verification, as well as a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control and a visual inspection of the returned product was conducted during the investigation.The customer returned the winged adapter and blue shrink tube from the smaller of the two lumens.The visual inspection noted the adapter was separated from the blue shrink tube.The shrink tube was attached to the extension tube and the clamp was present, however, the extension tube was cut proximal to the location of the silicone sleeve.The remainder of the catheter including the large shrink tube and extension tube, the tubing assembly and main catheter shaft were not returned.There is no evidence to suggest that the device was not manufactured to specification.The device is packaged with an ifu.The ifu includes warnings, precautions, recommendations and instructions for placement, use and maintenance of the device.Based on examination of the returned device, it appears that somehow excessive force was applied to the device.The most likely conclusion is that the device was subjected to forces beyond its intended design.Per the conclusion of quality engineering risk assessment, further risk reduction is not required.We have notified the appropriate internal personnel and will continue to monitor for similar events.

Event Description

The complaint catheter was placed in a patient, (date unknown).Approximately on week later, on (b)(6) 2015, the catheter became separated at the connection part between the tube and hub.It was replaced with another tpn double lumen tpn catheter set.No additional information has been provided.

• Brand Name: COOK TPN DOUBLE LUMEN TPN 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: 4902621
• MDR Text Key: 6536492
• Report Number: 1820334-2015-00423
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2018
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-7.0D-65
• Device Lot Number: 5593102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/05/2015
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• 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