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

Model Number	G04135
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number: pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that a triple lumen polyurethane central venous catheter luer lock hub was cracked.The device was inserted in the right internal jugular vein.The device was not removed from the patient as it is still in use.The patient did not require any additional procedures due to this occurrence.No adverse effects to the patient were reported.Additional information has been requested but has not been provided at the time of this report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.The complaint device was not returned for an evaluation.Therefore, a device failure analysis could not be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, manufacturing instructions and quality control data.A review of the device history records for the complaint device lot included the complete catheters, catheter sub-assemblies, and raw materials.The records showed there were no non-conformances related to this incident.In addition, a review of complaint history records revealed no related complaints have been received on the associated complaint device lots.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions do not re-sterilize catheter.Do not cut, trim or modify catheter or components prior to placement or intraoperatively.How supplied store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.The investigation found that the affected component is supplied to cook from a supplier.The supplier reviewed the product and lot history.Per the supplier, no evidence of abnormalities or contributing factors to the defect were noted.Excessive force applied in the field may have contributed to the failure mode.The supplier stated that there was no known relationship of the device to the reported event.A definitive conclusion could not be determined.Measures are in progress to address the reported failure mode.The appropriate internal personnel have been notified of this complaint and we will continue to monitor for similar complaints.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.
Event or Problem Description
There has been no new event information received since the last report.
Event or Problem Description
It was reported in additional information received on (b)(6) 2019 that this was the initial use of the device.On (b)(6)2019, additional event details were provided.The location of the crack was in the blue lumen.The catheter was placed on (b)(6) 2019.Perfusor tubing was attached to the hub, and no instruments were used to tighten or release the fitting from the device.No other substances were applied to the hub before the fitting was attached.A replacement catheter was not needed, as the same cvc catheter was used.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is 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 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.

• Brand Name: TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8336249
• Report Number: 1820334-2019-00326
• Device Sequence Number: 1064159
• Product Code: DQY
• UDI-Device Identifier: 00827002041356
• UDI-Public: (01)00827002041356(17)200927(10)8252310
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2020
• Device Model Number: G04135
• Device Catalogue Number: C-UTLM-501J
• Device Lot Number: 8252310
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 02/18/2019; 05/13/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 03/08/2019; 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PERFUSOR TUBING
• Patient Age: 2 YR
• Patient Weight: 12