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

Model Number G00219

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2021

Event Type  malfunction  

Event Description

As reported, during an unknown procedure two three-way plastic stopcock leaked.The physician was mixing two liquids, lipiodol and doxorubicin, by using the stopcock with two syringes, but found them leaking from a crack in the stopcock.A second three-way plastic stopcock was used, but the same leaking issue occurred.The procedure was completed by using a third same type device.No portion of the device was left within the patient.This did not result in the need for additional procedures or prolonged hospitalization.No adverse effects to the patient occurred due to this incident.

Manufacturer Narrative

Pma/510k # exempt.(b)(6).A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Correction: this report is being sent to indicate the complaint event is not reportable under fda 21 cfr part 803.Upon further investigation, this event is not reportable.Replacement of device to complete procedure is negligible harm and does not meet the criteria for a serious injury.An mdr guidance for manufacturers issued in 1997 stated that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established.This presumption will continue until either the malfunction has caused or contributed to no further deaths or serious injuries for two years, or the manufacturer can show through valid data that the likelihood of another death or serious injury as a result of the malfunction is remote.A detailed review of complaint history using a validated report revealed that there have been no deaths or serious injuries, per 21 cfr part 803.3, due to leaking of a three-way plastic stopcock from (b)(6)2018 through (b)(6)2021.Therefore, cook will cease malfunction reporting for events involving leaking of a three-way plastic stopcock.The recurrence of a serious injury or death for the same malfunction will trigger the resumption of mandatory reporting, per 21 cfr part 803.50.As such, this event no longer meets the set criteria for a reportable event; no further reports regarding this event will be submitted.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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12882655
• MDR Text Key: 284168363
• Report Number: 1820334-2021-02585
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)240204(10)9496210
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2024
• Device Model Number: G00219
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 9496210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DOXORUBICIN; LIPIODOL