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

Model Number	G00219
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
As reported, a three-way plastic stopcock was leaking lipodol and chemo drugs.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Additional event details have been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, a three-way plastic stopcock was leaking lipodol and chemo drugs.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Investigation evaluation: reviews of the complaint history, device history record, manufacturing instructions, and quality control procedures were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.In response to this incident, cook reviewed the device history record.The device history record for the same lot showed one relevant non-conformance for fitting, not properly secured for one scrap do not replace.There are also three nonrelevant nonconformances for this lot number.A database search for complaints on the reported lot found one additional complaint from the same customer for the same failure.The history record for the sub assembly found one relevant nonconformance for fitting, damaged for six scrap do not replace.There is also one nonrelevant nonconformance reported for this lot.A database search for complaints found no complaints from the field for these lots.This device does not come with an ifu.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The complaint was confirmed based on customer testimony.Cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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
No new patient or procedural information to report that was not included on the previous mdr.

• Brand Name: THREE-WAY PLASTIC STOPCOCK
• Common Device Name: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12387774
• Report Number: 1820334-2021-02082
• Device Sequence Number: 17026181
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)250420(10)13143558
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 04/20/2025
• Device Model Number: G00219
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 13143558
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1