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 03/19/2020

Event Type  malfunction  

Manufacturer Narrative

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 an unknown procedure, a three-way plastic stopcock leaked as the user was mixing lipiodol and an unknown chemotherapeutic agent.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.

Manufacturer Narrative

Initial report: as reported, during an unknown procedure, a three-way plastic stopcock leaked as the user was mixing lipiodol and an unknown chemotherapeutic agent.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, drawing, manufacturer¿s instructions, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.The information available provides objective evidence to support that the device was made to specifications.Cook has concluded that the findings from a previously completed root cause investigation aligns with the conclusion of this complaint.The stopcock stems molded of nylon 6 have the potential to absorb moisture, resulting in an increase in diameter and raising the potential for cracking of the stopcock body, which likely contributed to this incident.Per the quality engineering risk assessment no further action is required.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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.

Event Description

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

• 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: 9898565
• MDR Text Key: 200881196
• Report Number: 1820334-2020-00712
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)231220(10)9397168
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2023
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 9397168
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/24/2020
• Patient Sequence Number: 1