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

Model Number G02838

Device Problem Complete Blockage (1094)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Pma/510(k) #: preamendment.Investigation - evaluation it was reported by dr.Neil munjal form children¿s hospital, philadelphia, pa that the needle was obstructed.The complaint device was a cook single lumen pressure monitoring set (rpn: c-pms-250, lot number 9931541).On 02oct2019 it was noted in the preparation for placing an arterial line in the pediatric intensive care unit that the needles of two devices seemed obstructed during flushing.This defect was noted prior to patient contact while priming the catheter.One needle appeared to be completely obstructed and the other needle had a high-pressure stream.No damage or kinking to the needle was visible.The devices were discarded, and another was used to complete the procedure.The patient was reported to have had a good outcome.A review of the complaint history, device history record (dhr), instructions for use (ifu), and quality control of the device, as well as an inspection of unused product was conducted during the investigation.While no device was returned, cook pulled 100 bsdn-22-2.0 needles from a lot in the scope of the containment.A.015" wire guide was able to pass through all devices without resistance.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 (9931541) and the related needle component sub-assembly lots 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 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.A field action response was initiated but determined that no action is warranted at this time.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.During preparation for placing an arterial line in a pediatric patient in the user facility's icu, it was noted that the needles "seemed obstructed during flushing".One of the needles appeared completely obstructed while the other needle had a "high pressure stream".The devices were discarded and a third device was introduced to complete the procedure.The patient's outcome was described as "good".No adverse effects to the patient have been reported.

• 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: 9954868
• MDR Text Key: 201066658
• Report Number: 1820334-2020-00802
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002028388
• UDI-Public: (01)00827002028388(17)220806(10)9931541
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/06/2022
• Device Model Number: G02838
• Device Catalogue Number: C-PMS-250
• Device Lot Number: 9931541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2019
• 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