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 Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: value analysis coordinator.Pma/510(k) #: preamendment.(b)(4).Investigation - evaluation: (b)(6) hospital (united states) informed cook of an incident on (b)(6) 2019 involving two needles in c-pmsy-250 (single lumen polyethylene central venous catheter tray) trays from lot 9864806.The customer stated that while placing a peripheral arterial line in a 2.5kg patient, they were unable to get blood return despite confirming with ultrasound that the needle was in the artery.The user attempted to insert the wire, but was unable.They replaced the needle with another needle from the same lot, and had the same issue.They were eventually able to advance the wire through the second needle and into the patient with difficulty.A review of the complaint history, device history record (dhr), and quality control, as well as a functional test and visual inspection of the returned device, as well as an inspection of unused product, was conducted during the investigation.One used needle, an opened tray, and 5 unopened trays were returned to cook for evaluation.Upon functional test, the used wire was advanced through all of the needles successfully without difficulty.Visual inspection found no damage on any of the devices.This analysis concluded that there is no evidence these devices were manufactured out of specification.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 (9864806) and the related needle component sub-assembly lot (ic9732187) revealed no non-conformances.However, a database review revealed six other events related to this failure mode.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.Cook also reviewed product labeling.The instructions for use [ifu_t_ulmbh_rev5] state "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, evaluation of the 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.A field action response was initiated but determined that no action is warranted at this time.Cook will continue to monitor for similar complaints.
Event or Problem Description
It was reported that the wire guide would not pass through the needle included in a single lumen polyethylene central venous catheter tray.While placing a peripheral arterial line, the physician was unable to get blood return despite using an ultrasound for visual aid.At this point, the physician could not advance the wire guide through the needle to complete the procedure.After "a couple of attempts", the physician obtained a second kit.Unfortunately, the physician ran into the same issue.Eventually, the physician was able to get the wire through the needle "with some difficulty" but "felt a pop" right before.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: 9830940
• Report Number: 1820334-2020-00606
• Device Sequence Number: 743058
• Product Code: DQY
• UDI-Device Identifier: 00827002028548
• UDI-Public: (01)00827002028548(17)210712(10)9864806
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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: 9864806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 2