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

Model Number	G00219
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address= phone: (b)(6); postal code: (b)(6).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 or Problem Description
As reported, during an unknown procedure, a three-way plastic stopcock leaked.During the same procedure, another three-way plastic stopcock also leaked.That device will be reported under patient identifier (b)(6).A third stopcock was used to complete the procedure.There were no adverse effects to the patient.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
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 01jan2018 through 22dec2021.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.
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information was received 05dec2021.An unspecified syringe was attached to the device.

• Brand Name: THREE-WAY PLASTIC STOPCOCK
• Common Device Name: 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: 12862390
• Report Number: 1820334-2021-02567
• Device Sequence Number: 17194782
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)220331(10)7794436
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: G00219
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 7794436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 12/05/2021; 12/22/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/14/2021; 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown