MAUDE Adverse Event Report: COOK INC THREE-WAY PLASTIC STOPCOCK; KGZ ACCESSORIES, CATHETER

Catalog Number PTWS-2FLL-MLL-R

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint devices will not be returned.Nine unused devices from the same lot will be returned, per the reporter.Occupation = lead ir tech.Pma/510(k) number = exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a transarterial chemoembolization (tace) procedure, two cook three-way plastic stopcocks leaked during administration of chemotherapy.A third device from a different lot was used to complete the procedure successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Initial report: as reported, during a transarterial chemoembolization (tace) procedure, two cook three-way plastic stopcocks leaked during administration of chemotherapy.A third device from a different lot was used to complete the procedure successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation - evaluation reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and specifications of the device were conducted during the investigation as well as a visual exam and functional test of the nine returned unused devices.The complaint device was not returned; however, the complainant returned nine unopened/unused devices for review.All nine devices were opened and leak tested ¿ all devices failed the leak test due to cracks noted in the stopcocks.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted a review of the provided lot revealed two additional complaints from the same facility, for the same failure mode.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.A capa was opened due to consistent complaint history of this product surrounding cracking and subsequent leaking of stopcocks.The root cause of cracking/leaking stopcocks was determined to be stopcock stems molded of nylon 6 have the potential to absorb moisture resulting in an increase in diameter raising the potential for cracking of the stopcock body.A clinical effects analysis was created to measure the risk associated with cracking of the stopcock for the period of 24aug2o12 - 31dec2018.The results indicated that the associated risk is low to very low.According to the cea, the current rate of occurrence is 0.00216% which is lower than the rate of occurrence when the capa was opened.Based on the information provided and the examination returned of the unused/unopened nine devices, investigation agrees with the findings of the previously initiated capa.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: THREE-WAY PLASTIC STOPCOCK
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9590301
• MDR Text Key: 177840578
• Report Number: 1820334-2020-00109
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)200903(10)6176888
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2020
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 6176888
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1