MAUDE Adverse Event Report: COOK INC SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY; DQY CATHETER, PERCUTANEOUS

Model Number G02854

Device Problem Complete Blockage (1094)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: (b)(6).Pma/510(k) #: preamendment.Investigation - evaluation: a customer at vidant health (united states) reported that the needle in a c-pmsy-250 (single lumen polyethylene central venous catheter tray) from lot 10133951 created resistance with a wire guide prior to an arterial line placement on (b)(6) 2020.The customer reported that when they were testing the device at the patient's bedside, they had difficulty inserting the wire through the needle.The device did not make patient contact.A review of the complaint history, device history record (dhr), instructions for use (ifu), and quality control was conducted during the investigation.One incomplete used tray without the needle was returned to cook for evaluation.The wire was able to be fully inserted through the catheter without any issues, though the needle could not be tested.Additionally, a document-based investigation evaluation was performed.The device master record (dmr) found that proper procedures and inspections are in place to prevent the distribution of non-conforming product.A review of the device's design history files found that the product is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (10133951) and the associated needle component lot revealed no non-conformances.However, based on the dhr review, there is evidence of potential nonconforming material in house and in field.As the needle is supplied by cook polymer technology (cpt), cook initiated a supplier corrective action request in response to this issue.As there is evidence of potentially nonconforming material from the same supplier lots in other events, cook initiated product containment for affected in house product and to prevent redistribution of product in the field.It should be noted that there was one additional event reported to cook associated with the complaint device needle component lot.Cook also reviewed product labeling.The instructions for use [ifu_t_ulmbhce_rev6] state "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no returned product, and the results of our investigation, a definitive root cause was established as a deficiency in supplier manufacturing/quality control.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

It was reported that there was resistance when inserting a wire guide through the needle of a single lumen polyethylene central venous catheter tray during an arterial line placement procedure.The user was testing the device bedside before starting the procedure when the resistance was noted.The device did not make patient contact.

• Brand Name: SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY
• 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: jennifer canada ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 9971619
• MDR Text Key: 202223625
• Report Number: 1820334-2020-00833
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002028548
• UDI-Public: (01)00827002028548(17)211001(10)10133951
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: G02854
• Device Catalogue Number: C-PMSY-250
• Device Lot Number: 10133951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Date Manufacturer Received: 04/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2019
• 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