MAUDE Adverse Event Report: COOK INC TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTER; KGZ ACCESSORIES, CATHETER

Catalog Number PTBYC-RA

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Occupation = unknown.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 testing of a device, a tuohy-borst large bore clear plastic sidearm adapter leaked.The reporter plugged the device with a finger, screwed the valve which stops flow, and injected five milliliters of water; noting that the end with the valve would not seal.The device did not make patient contact.During the same procedure, five devices from a different lot also leaked; this will be reported under patient identifier 300037.There has been no report that the patient experienced any adverse effects from this event.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: see b5.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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

Additional information was received 22jul2020.An unknown 0.014 inch guidewire was used during the procedure.The devices had been stored in a storage bin in the cath lab.

Manufacturer Narrative

Additional information: b5: additional information received 06aug2020 confirmed that there were no adverse effects to the patient as a result of this incident.The patient's outcome was good.D10, h3: information was received 29jul2020 confirming that the devices would not be returned to cook for investigation.Summary of event: as reported, during testing of a device, a tuohy-borst large bore clear plastic sidearm adapter leaked.The reporter plugged the device with a finger, screwed the valve which stops flow, and injected five milliliters of water; noting that the end with the valve would not seal.The device did not make patient contact.During the same procedure, five devices from a different lot also leaked; this was reported under patient identifier: (b)(6).Additional information was received 22jul2020.An unknown 0.014 inch guidewire was used during the procedure.The devices had been stored in a storage bin in the cath lab.There has been no report that the patient experienced any adverse effects from this event.Investigation evaluation: a review of the complaint history, device history record, drawing, documentation, manufacturing instructions, and quality control was conducted during the investigation.The complaint device was not returned for investigation; therefore, a visual inspection of the device was not conducted.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The information provided upon review of complaint file, device history record, complaint history, and device master record provide objective evidence to support that the device was manufactured to specification.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A device master record review was performed, including device specifications, drawings, manufacturing instructions, and quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed product labeling.The product label indicates that the maximum pressure the sidearm adapter can withstand is 300 psi.Based on the information provided and the results of the investigation, cook has concluded that a definitive conclusion could not be determined.The risk analysis for this failure mode was reviewed and no action was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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

Additional information received 06aug2020 confirmed that there were no adverse effects to the patient as a result of this incident.The patient's outcome was good.

• Brand Name: TUOHY-BORST LARGE BORE CLEAR PLASTIC SIDEARM ADAPTER
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10078886
• MDR Text Key: 199989874
• Report Number: 1820334-2020-00976
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002062993
• UDI-Public: (01)00827002062993(17)240726(10)9909394
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PTBYC-RA
• Device Lot Number: 9909394
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1