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 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

Operator of device: other: did not make patient contact, found by manufacturer.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, two three-way plastic stopcocks leaked.According to the reporter, the leak occurred continuously from the middle of the hub (refer to mdr 1820334-2019-00145).Nine unused devices were also returned to the manufacturer under this complaint for investigation.Of the nine devices returned, five failed leak tests during the investigation process (refer to this report).

Manufacturer Narrative

Investigation/evaluation: a review of the complaint history, device history record, documentation, quality control, specifications, and a visual inspection of the returned device as well as an inspection of unused product of the returned device was conducted during the investigation.The visual inspection of the returned package confirmed that eleven total products were sent back to the manufacturer.Two used devices were returned, and both were cracked and leaking.The cracks were noted on the attached images and extend from the main body of the stopcock to the hex nut.Four of the unused products were found to be undamaged and did not leak.However, five of the unused products were found to have similar cracks on the stopcock body, extending to the hex nut.Leakage occurred from this area.The five, leaking and cracked, unused products were captured under (b)(4).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 there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and a gap was discovered.Actions are being taken to address the design of the product as this is currently determined to be the root cause.Field action was previously requested, assessed, and concluded that no field action was warranted as the risk evaluation was determined to be low and unlikely to result in an adverse health consequence.Based on the information provided and the examination of the returned product, investigation has concluded that this event can be traced to the device being inadequately design for the purpose.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being conducted to address this failure mode.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: 8285466
• MDR Text Key: 134869095
• Report Number: 1820334-2019-00272
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)210706(10)7097995
• 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: 02/15/2019

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: Other
• Device Expiration Date: 07/06/2021
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 7097995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1