MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PRESSURE MONITORING SET; DQY CATHETER, PERCUTANEOUS

Model Number N/A

Device Problem Complete Blockage (1094)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.Pma/510(k) #: preamendment.Investigation - evaluation: a customer at virginia commonwealth university health system (united states) reported that two needles in c-pms-250 (single lumen pressure monitoring set) sets from lot 9961061 were occluded during an arterial line placement on (b)(6) 2019.The customer stated that they were not able to pass a wire guide through the needle once it was inserted into the patient.The patient did not experience adverse effects.A review of the complaint history, device history record (dhr), instructions for use (ifu) and quality control of the device, as well as a visual inspection and functional test of unused product returned by the user was conducted during the investigation.Thought the complaint devices were not returned, the user facility returned three unopened devices from the same lot as the complaint devices.Visual inspection of the devices revealed no visible damage or abnormalities.The wires for each set were inserted through the needles proximally and distally without any resistance.Nothing exited the lumens of the needles.Additionally, a document-based investigation evaluation was performed.The device master record (dmr) concluded 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 (9961061) and the related needle component lot revealed no recorded non-conformances.A database search found one additional complaint (mfg.Report reference #:1820334-2020-00802) for the same failure mode with devices from the same 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.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, examination of unused 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 a wire guide would not pass through the needles included in two single lumen pressure monitoring sets.The user was attempting to use the seldinger technique during an arterial line placement procedure when the devices failed.No adverse effects to the patient were reported other than "requiring multiple sticks".

• Brand Name: SINGLE LUMEN PRESSURE MONITORING SET
• 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: 9959019
• MDR Text Key: 201913082
• Report Number: 1820334-2020-00812
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002028388
• UDI-Public: (01)00827002028388(17)220820(10)9961061
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-250
• Device Lot Number: 9961061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2019
• 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