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 No Patient Involvement (2645)

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported that a three-way plastic stopcock was found to be leaking fluid.This was observed prior to patient contact, and another similar device was used to complete the procedure.The type of procedure was not provided.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.This incident was previously reported to capture the initially reported failure mode.However, following a cross functional assessment of the risks posed by this failure mode, it was determined that the risk to the patient is not substantial enough to warrant reporting under part 21 cfr part 803 reporting regulations.As such, this incident has been reassessed and is no longer reportable.Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, manufactures instructions, quality control, specifications, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the was cracked on the body.The thru-hole was verified to be open by use of a pin gauge.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there was one other reported complaint for this lot number.Furthermore, a review of the manufactures instructions and documentation revealed relevant information surrounding the mold used for this device.The material used for this device has the potential to absorb moisture, resulting in an increase in diameter, thus raising the potential for cracking the stopcock body.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause can be traced to device designed.Measures are being conducted to address this failure mode.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the risk assessment no further action is required.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
• MDR Report Key: 8010345
• MDR Text Key: 125294963
• Report Number: 1820334-2018-03187
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)200824(10)6148804
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2020
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 6148804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 11/20/2018
• Supplement Dates FDA Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1