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 Problems Component(s), broken (1103); Material Separation (1562)

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

Event Date 05/15/2015

Event Type  Injury  

Event Description

The cook double lumen tpn catheter line was initially inserted under general anesthetic on (b)(6) 2015.The line broke and needed repair twice within 12 days after placement.The damaged line was removed under anesthesia on (b)(6) 2015.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not required any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, documentation, instructions for use (ifu), quality control, and a visual inspection and dimensional verification of the returned device were conducted during the investigation.A visual examination of the returned product revealed complete separation of the catheter at 16.5cm distal to the manifold.There was also suture and blood/biomaterial on the separated portion of the catheter at 3.5cm distal from the break.The cuff was 6.4cm distal from the break.The noted separation was proximal to the cuff and the suture; which confirms separation outside the body (as was noted in the customer statement that the catheter was broken when they moved the patient).There is no evidence to suggest that the device was not manufactured to specification.The device is packaged with an instructions for use (ifu); which gives intended use, warnings, precautions, recommendations and instructions regarding use of a double lumen catheter.The ifu includes the precaution, "extreme caution should be used in placement and monitoring." it is feasible to suggest that the device failure was caused by the excessive forces.We have notified appropriate internal personnel and will continue to monitor for similar events.Per the quality engineering risk assessment (qera) further risk reduction is not required.

Event Description

The cook double lumen tpn catheter line was initially inserted under general anesthetic on (b)(6) 2015.Initially the catheter was caught on the railing of the bed and broke when the child was lifted out of the bed.The line broke and needed repair twice within 12 days after placement.The damaged line was removed under anesthesia on (b)(6) 2015.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not required any additional procedures nor experience any adverse effects due to this occurrence.

• 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: 4919519
• MDR Text Key: 6011098
• Report Number: 1820334-2015-00435
• Device Sequence Number: 1
• Product Code: FOZ
• 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,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2018
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-7.0D-65
• Device Lot Number: 5588276
• Other Device ID Number: SEE FIELD H10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/15/2015
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• 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): Other; Required Intervention