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

Model Number G07935

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problem No Code Available (3191)

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that the redo double lumen tpn catheter set leaked at the juncture between the two catheters lumens.During total parenteral nutrition (tpn) via central venous catheter, while flushing both lumens at the same time, it was discovered that the blue hub lumen was occluded.Under the direction of an anesthetist, the staff was instructed to attempt to open the lumen with a 1ml syringe filled with heparin.While actuating the plunger, resistance was lost.It was observed that liquid was emerging from the area of the juncture between the two catheter lumens.The other lumen with a red hub was flushed without complication.The redo double lumen tpn catheter was replaced with a venous port.This was the fifth replacement of this type of central venous catheter in 2018 for this patient.Related mfr.Reports include 1820334-2019-00243, 18203342019-00244, 1820334-2019-00245, 1820334-2019-00246.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Results code: appropriate term/code not available (4247) - occluded, device.Investigation - evaluation.A review of the complaint history, device history record, instructions for use, manufacturing instructions and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record found that current process and quality inspection checks are in place to ensure the functionality and device integrity prior to device shipment.A review of the device history record for lot 8429658 and sub component lot ni8429657 found no nonconformances that could have contributed to the device failure mode.It should be noted that there were no other complaints associated with these lot numbers.Since no additional nonconformances and no other complaints with the same failure mode exist under these lots, there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify the attending physician immediately suggested catheter maintenance: the instructions state that the catheter should be maintained with a continuous saline or heparinized saline drip.If a heparin lock is utilized, then the lumen should be checked at least once every 24 hours and flushed before and after use.Based on the information provided, no returned product and the results of our investigation, a definitive root cause could not be established.It is possible that the reported lumen obstruction contributed to the lumen leaking due to the pressure build up quality engineer risk assessment 603 rev 002 was written to address the failure of the blocked lumen.The appropriate personnel have been notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new event description information to report at this time.

• Brand Name: REDO 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
• MDR Report Key: 8290090
• MDR Text Key: 134507418
• Report Number: 1820334-2019-00242
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002079359
• UDI-Public: (01)00827002079359(17)201220(10)8429658
• Combination Product (y/n): N
• PMA/PMN Number: K950118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2020
• Device Model Number: G07935
• Device Catalogue Number: C-TPNS-5.0D-65-12-REDO
• Device Lot Number: 8429658
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR