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 Consequences Or Impact To Patient (2199)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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

As reported, during an embolization procedure involving a patient of unknown age and gender, a leak was observed using a three-way plastic stopcock.Per the initial reporter, "pressure leaks on the wall at the faucet of 2 consecutive embolization procedures lipiodol and doxorubicin".An unknown manufacturer's syringe was also used with the product.Additional information received from the user states that the physician believes that the unknown syringe was the source of the leak.The first instance is reported under patient identifier (b)(6).The second instance is reported under patient identifier (b)(6).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation/evaluation: reviews of the documentation, drawing, manufacturer¿s instructions, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and no product returned, investigation has concluded that there is no failure mode associated with this device.Reportedly, the user confirmed that the issue in this situation was a result of another manufacturer¿s syringe, not the cook device.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

Additional information was received from the physician confirming that this issue was due to the syringe, not cook's three-way plastic stopcock.

• 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: 8772481
• MDR Text Key: 151764544
• Report Number: 1820334-2019-01640
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1