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

Model Number	G00219
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #- 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 a chemotherapy treatment, a three-way plastic stopcock "melted".No portion of the device was left inside the patient.The patient did not require any additional procedures or prolonged hospitalization.The patient did experience any adverse effects due to this occurrence.Additional information has been requested.
Event or Problem Description
Additional information was received 05aug2021.The procedure involved a hepatic chemoembolization using farmarubicina.An unknown syringe was connected to the stopcock.Additionally, twenty unused devices from the same lot were returned to cook.On 04aug2021, leak testing found that nine of the stopcocks were cracked, eight of which leaked.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, h6 (annex a).Correction: h8.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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
No new patient or event information since the last report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary: as reported, during a chemotherapy treatment, a three-way plastic stopcock "melted".The procedure involved a hepatic chemoembolization using farmarubicina.An unknown syringe was connected to the stopcock.No portion of the device was left inside the patient.The patient did not require any additional procedures or prolonged hospitalization.The patient did experience any adverse effects due to this occurrence.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record (dhr), drawing, manufacturing instructions, and quality control data.The complainant returned 20 unused devices to cook for investigation.No damage was initially noted to any of the stopcocks.Further request was made to leak check each stopcock.A syringe filled with water was attached to the stopcock.Cracks were found during the leak check.In total, eight devices were cracked and leaked, one was cracked and did not leak, and eleven were not cracked and did not leak.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There are 100% inspection activities in place to identify this failure prior to distribution.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 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.

• 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: 12144533
• Report Number: 1820334-2021-01735
• Device Sequence Number: 17182324
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)240109(10)9431766
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2021

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: 01/09/2024
• Device Model Number: G00219
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 9431766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 08/04/2021; 10/01/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/25/2021; 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1