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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2020

Event Type  malfunction  

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 Description

It was reported that a three-way plastic stopcock that was to be used in a transarterial chemoembolization (tace) procedure was leaking from the "bottom".The patient was a (b)(6) year old female undergoing a tace procedure in the liver.Before the procedure, the physician mixed the relevant medications.A mix of doxorubicin and lipiodol was to be delivered to the patient.While flushing the first device, it was found that the three way stopcock was leaking from the bottom.Another device from the same lot was opened, however, leakage from the bottom of the stopcock was again noted.A third device from another lot did not experience leakage and was able to be used successfully during the procedure.No other adverse effects have been reported.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: b4 field was initially left blank on the final report.The date sent should be 13may2020.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 Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: product identifier, d4 - rpn.H6 method code: analysis of data provided by user/third party (4112).Investigation evaluation: (b)(6) hospital, informed cook on 09apr2020 of an incident involving a three-way plastic stopcock (rpn: ptws-2fll-mll-r) from lot # 8367006.The stopcock was leaking at the bottom.A video representing the failure was provided, showing the leakage at the cap of the stopcock, opposite the lever.The customer attempted to use another device from the same lot, but the failure was noted again.A third device from a different lot was used and completed the procedure with no adverse effects to the patient noted.A review of documentation including the complaint history, device history record, drawing, manufacturing instructions and quality control, as well as a visual inspection and functional test of the returned unused devices was conducted during the investigation.Two unused stopcocks from the same lot were returned for evaluation.Physical examination of the devices showed no cracks or damage to either device.The stopcock levers moved freely with normal resistance.Both stopcocks were leak tested with the lever in all positions and no leaks were detected.A video of the failed device was also returned.From the video, a leak can be seen from the plastic hex hut, opposite of the lever.No damage to the device could be confirmed.There is no evidence to conclude that the devices were manufactured out of specification.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record for lot 8367006 found no relevant nonconformances that could have contributed to the failure mode.It should be noted that there were no additional complaints reported for this lot number.There is no evidence to suggest that nonconforming product exists in house or in the field.Cook could not review product labeling, as no failure related labeling is supplied with the complaint device.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a possible environmental condition contributed to this incident.A previously opened capa investigated this issue and found that a possible cause for leakage from cracking was due to elevated humidity conditions.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.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.

• 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: 9979271
• MDR Text Key: 196210100
• Report Number: 1820334-2020-00847
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)221110(10)8367006
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2022
• Device Model Number: N/A
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 8367006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO 35 WIRE
• Patient Age: 76 YR
• Patient Weight: 52