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

Model Number	G02854
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Pma/510(k) #: preamendment.Investigation - evaluation.A customer at seton dell children's hospital (united states) reported that the needle in a c-pmsy-250 (single lumen polyethylene central venous catheter tray) from lot 9402033 did not give blood return during an arterial pressure monitoring procedure on (b)(6) 2019.The customer stated that when they inserted the needle, they did not get "flashback" and had difficulty inserting the wire guide through the needle.The patient did not experience adverse effects.A review of the complaint history, device history record (dhr), instructions for use (ifu), and quality control, as well as a visual inspection and functional test of the returned device was conducted during the investigation.One used 22g needle was returned to cook for evaluation.Upon visual inspection, no damage or biomatter was noted.A functional test found that the needle was able to be flushed without difficulty.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 (9402033) and the related needle component lot revealed no recorded non-conformances.A database search did not find any other events associated with the reported device lot.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 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 or Problem Description
It was reported that the needle of a single lumen polyethylene central venous catheter tray did not give blood return during an arterial pressure monitoring procedure.After insertion, saline was flushed through the needle and the wire guide was attempted to be advanced through the needle.When the user inserted the needle, they did not get "flashback" and experienced difficulty inserting the wire guide through the needle.It was stated that "it is suspected that the vessel had not been accessed".The patient was already in the icu at the time of the event and was receiving the device for arterial pressure monitoring.A new kit was used to complete the procedure.No adverse effects to the patient have been reported.

• 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: 9959067
• Report Number: 1820334-2020-00813
• Device Sequence Number: 16846069
• Product Code: DQY
• UDI-Device Identifier: 00827002028548
• UDI-Public: (01)00827002028548(17)210712(10)9402033
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2020

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: 07/12/2021
• Device Model Number: G02854
• Device Catalogue Number: C-PMSY-250
• Device Lot Number: 9402033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1