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 Information (3190)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 chemotherapy infusion, the three-way plastic stopcock leaked from the junction of the stopcock and the hexagonal part of the device while in the off position.Reportedly, the patient did not receive the full chemotherapy prescription due to this occurrence.Additional information regarding patient outcome has been requested, but is not available at this time.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, documentation, manufacturing instructions, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.Both opened and unopened samples were returned for evaluation.The visual inspection of the returned devices confirmed the presence of leaks in samples in both the opened and unopened product groups which were tested.All but one of the used devices leaked during testing.Cracks were observed to be the cause of the leaks.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 were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause was determined to be that stopcock stems molded of a particular material have the potential to absorb moisture, resulting in an increase in diameter raising the potential for cracking of the stopcock body.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.

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: 7521770
• MDR Text Key: 108503365
• Report Number: 1820334-2018-01282
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)201201(10)6418958
• 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: 07/16/2018

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 Catalogue Number: PTWS-2FLL-MLL-R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other