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U.S. Department of Health and Human Services

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

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COOK INC SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY DQY CATHETER, PERCUTANEOUS Back to Search Results
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.

 
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Brand NameSINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY
Type of DeviceDQY 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 Key9971619
MDR Text Key202223625
Report Number1820334-2020-00833
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/17/2020
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG02854
Device Catalogue NumberC-PMSY-250
Device LOT Number10133951
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/02/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/25/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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