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 Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2019

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 during an unknown procedure, a three-way plastic stopcock leaked.According to the reporter, the leak occurred continuously from the middle of the hub.A section of the device did not remain inside the patient¿s body.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.Additional information regarding event details and patient outcome has been requested, but is not available at this time.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the complaint history, device history record, quality control, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one used, plastic 3-way stopcock, ptws-2fll-mll-r, was returned for investigation.The device had an orange substance on the exterior.Leakage was noted from a crack as well as underneath the hex nut.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 also be noted a search for other complaints associated with this lot number yielded this complaint and (b)(4).(b)(4) was reported for the same device failure and from the same facility.A sales and complaint report was completed to determine how often this failure has happened over the past three years, including this and the additional complaint with this product lot number.The occurrence rate was determined to be within the current range captured by the risk documentation associated with this device failure.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and a gap was discovered.It is noted that within the quality control procedures, the products tested on high pressure must be discarded.However, the work order does not notate or list that those devices from the lot were in fact checked or discarded.Measures are being conducted to address this failure mode.Based on the information provided and the examination of the returned product, investigation has concluded that this failure can be traced to the device being inadequately designed for the purpose.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 quality engineering 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: 8276720
• MDR Text Key: 134187306
• Report Number: 1820334-2019-00143
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)220214(10)7675135
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

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: 02/14/2022
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 7675135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: 03/08/2019
• Supplement Dates FDA Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1