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

Model Number N/A

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2022

Event Type  malfunction  

Event Description

It was reported that the medial and proximal lumens of a triple lumen polyurethane central venous catheter were sluggish when flushed.The central line kit was opened and the physician attempted to flush the catheter prior to insertion.The distal lumen flushed well, while the medial and proximal lumens were very sluggish.Another kit was opened to complete the procedure successfully.The complaint device did not make patient contact.

Manufacturer Narrative

Initial reporter occupation: materials.Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

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.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation: (b)(6) hospital (united states) informed cook on 03may2022 of an issue with a triple lumen polyurethane central venous catheter set (rpn: c-utlm-501j; lot number: unknown).The set was opened and the physician flushed the catheter prior to insertion.The distal lumen flushed well; however, the medial and proximal lumens were very sluggish when flushed.A replacement set was used to complete the procedure successfully.The complaint device did not make patient contact.Reviews of documentation including quality control procedures and instructions for use (ifu), as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One complaint device was received to cook for evaluation.The red lumen of the three-lumen catheter would not flush.The blue lumen would flush but very slowly.The white lumen would flush without any difficulties.Additional leak testing was done by the investigator.All three lumens were able to be flushed on the returned cook device.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide the lot number for the complaint device.Cook reviewed the sales history for this customer and was unable to identify the complaint lot.The device history record could not be reviewed.Based on this information, the device was manufactured to specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The product ifu, [c_t_ulmbhce_rev8] ¿uncoated and heparin-coated central venous catheters,¿ provides the following information to the user related to the reported failure mode: ¿suggested catheter maintenance -to prevent clotting or possibility of air embolus, the double-lumen¿s #2 lumen, and the triple-lumen¿s #2 and #3 lumen¿s should be filled with heparinized saline solution (100 unites of heparin per cc of saline is usually adequate) prior to catheter introduction.-before using any lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumens should be flushed with normal saline between administrations of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin lock.How supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.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.¿ based on the information provided, inspection of the returned device, and the results of the investigation, cook concluded the cause of event to be component failure.The distal lumen flushed well, but the medical and proximal lumens were sluggish when flushed.It¿s likely the lumen was not fully opened for an unknown reason.During testing, the device was able to be flushed.Nothing was found inside the lumens that could contribute to the reported failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14408820
• MDR Text Key: 291883501
• Report Number: 1820334-2022-00726
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UTLM-501J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/16/2022
• Supplement Dates Manufacturer Received: 05/26/2022; 12/21/2022
• Supplement Dates FDA Received: 05/31/2022; 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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