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

Catalog Number PTWS-2FLL-MLL-R

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 11/26/2019

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, prior to patient contact, a crack was found in a three-way plastic stopcock.The physician was mixing two liquids using two unknown syringes, and the liquid was reportedly "blowing up" due to the crack in the stopcock.The device did not make contact with any patient.There has been no report that the patient required any additional procedures or experienced any adverse effects due to this event.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Initial report.As reported, prior to patient contact, a crack was found in a three-way plastic stopcock.The physician was mixing two liquids using two unknown syringes, and the liquid was reportedly "blowing up" due to the crack in the stopcock.The device did not make contact with any patient.There has been no report that the patient required any additional procedures or experienced any adverse effects due to this event.Investigation evaluation.Reviews of the complaint history, device history record, drawing, manufacturer¿s instructions, quality control procedures, and visual inspection of the device were conducted during the investigation.The complaint device was not returned; however, used devices were provided for investigation under patient identifier (b)(6).Two prior-to-use ptws-2fll-mll-r stopcocks were returned in their individual packages along with two additional empty packages.No damage noted.Red-orange substance on stopcocks.A leak test was performed for both stopcocks.No leaks were found.Additionally, document-based investigation evaluation was performed.The evidence indicates the product was made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.There were no non-conformances noted for this lot.No complaints for this lot have been reported.Adequate inspection activities have been established and there is objective evidence that the dhr was fully executed.Thus, there is no evidence to suggest that there are any nonconforming devices in the lot or in the field.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and no product returned, investigation has concluded that a root cause for this event could not be determined.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.

• 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: 9466735
• MDR Text Key: 175850574
• Report Number: 1820334-2019-03108
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)240204(10)9496210
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2024
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 9496210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Date Manufacturer Received: 04/06/2020
• Patient Sequence Number: 1