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 Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k # 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 chemotherapy treatment, a three-way plastic stopcock "melted".Additional information has been requested.

Manufacturer Narrative

Event summary: cook was informed of an incident involving a three-way plastic stopcock from an unknown lot.During a procedure with chemotherapy liquids, the three-way stopcock was leaking.No adverse effects to the patient were reported.Investigation - evaluation: a document-based investigation was performed including a review of manufacturing instructions, quality control data, and drawings.The complainant did not return the complaint device to cook for investigation.A device history review could not be performed as no device lot number was provided in this case.At this time, cook concluded that no non-conforming product from this lot exists in house or in the field.There are 100% inspection activities in place to identify this failure prior to distribution.Based on the limited available information, cook has concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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

Additional information was received on 21sep2021: the procedure was an hepatic chemoembolization.The drug was farmarubicina, and the stopcock was connected to a syringe to inoculate the drug.The products were noted to be cracked rather than melted.

• 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: 12144702
• MDR Text Key: 261940328
• Report Number: 1820334-2021-01736
• Device Sequence Number: 1
• Product Code: KGZ
• 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: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1