MAUDE Adverse Event Report: COOK INC DOUBLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET; DQY CATHETER, PERCUTANEOUS

Model Number G04035

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510(k): not exempt, pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The double lumen polyurethane central venous catheter set (4 french, 8cm) was used for the patient in a right subclavian central venous catheter placement procedure and it was discovered that the luer lock hub was cracked.No patient harm has been reported.The complaint device is still in use by the patient, as the cracked lumen has been clamped and the other lumen is being used for infusions.The device will not be returned to the manufacturer.The reporter advised that the nurse manager will be able to provide more details on 16 jan 2019.Despite follow up requests there has been no additional information provided.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

A4 - weight: 3800 grams.Investigation/evaluation: a review of the complaint history, device history record, instructions for use, manufacturing instructions and quality control data 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.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record found no related nonconformances in the main or subassembly lots that could have contributed to this failure mode.A review of the raw material lots stated that they were ¿ok¿ during incoming inspection.It should be noted that there was one similar complaint for subassembly lot sa7442570 and it¿s related raw materials.In that complaint, leakage of the catheter was reported; however, upon examination of the returned catheter, no leakage was detected, and no cracks were noted.There is no evidence that nonconforming product exists in house or in the field.The investigation found that the affected component is supplied to cook from a supplier.The supplier reviewed the product and lot history, and no evidence of abnormalities or contributing factors to the defect were noted.Excessive force may have contributed to the failure mode.The supplier stated that there was no known relationship of the device to the reported event.The supplier is supporting measures by the manufacturer to address this issue.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: ¿¿if heparin-induced thrombocytopenia is suspected, the heparin-coated catheter should be immediately removed.Do not power inject contrast medium through catheter.Catheter rupture may result.Use of 10 ml or larger syringe will reduce the risk of catheter rupture.¿ precautions: ¿¿do not cut, trim or modify catheter or components prior to placement or intraoperatively.Patient movement can cause catheter tip displacement.Catheter should not be used for long-term indwelling applications.For heparin coated devices, standard flushing procedures are recommended.¿ based on the information provided, no returned product and the results of our investigation, it was concluded that a definitive root cause could not be established.Appropriate measures have been taken to address this failure mode.Per the quality engineering risk assessment, no further action is required.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

It was reported in additional information received on 20feb2019, that the device was connected to perfusor tubing before the hub cracked.No instruments were used to tighten or release a fitting to the hub, and no alcohol or substance was applied to the hub before the fitting was attached.The catheter has not been removed, as the working lumen is still being used.

Manufacturer Narrative

A4 - weight: 3800 grams 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.

• Brand Name: DOUBLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8296946
• MDR Text Key: 136272560
• Report Number: 1820334-2019-00348
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002040359
• UDI-Public: (01)00827002040359(17)200818(10)NS8154099
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2020
• Device Model Number: G04035
• Device Catalogue Number: C-UDLM-401J
• Device Lot Number: NS8154099
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE
• Patient Age: 1 MO