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

Model Number	N/A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.Occupation: assistant nurse manager.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 they were testing the device at the patient's bedside though the device did not make patient contact.A review of the complaint history, device history record (dhr), instructions for use (ifu), 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.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-conformance's.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 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 or Problem 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
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9962800
• Report Number: 1820334-2020-00826
• Device Sequence Number: 19545191
• Product Code: DQY
• UDI-Device Identifier: 00827002028548
• UDI-Public: (01)00827002028548(17)211001(10)10133951
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/15/2020

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: 10/01/2021
• Device Model Number: N/A
• Device Catalogue Number: C-PMSY-250
• Device Lot Number: 10133951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1