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

Catalog Number	PTBYC-RA
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The three devices used during the procedure were discarded and will not be returned.The two devices that were tested by the reporter will be returned.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 or Problem Description
As reported, during an unknown procedure, five tuohy-borst large bore clear plastic sidearm adapters leaked.Another manufacturer's device was used to complete the procedure.Three of the devices were reported to have leaked during the procedure and two of the devices leaked during testing.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 reporter also tried another device from a different lot, which also reportedly leaked.The leak associated with the other lot will be reported under patient identifier (b)(6).There has been no report that the patient experienced any adverse effects from this event.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 or Problem 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5: additional information received (b)(6) 2020, 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 (b)(6) 2020, confirming that the devices would not be returned to cook for investigation.Summary of event: as reported, during an unknown procedure, five tuohy-borst large bore clear plastic sidearm adapters leaked.Another manufacturer's device was used to complete the procedure.Three of the devices were reported to have leaked during the procedure and two of the devices leaked during testing.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 reporter also tried another device from a different lot, which also reportedly leaked.The leak associated with the other lot was reported under patient identifier (b)(6).Additional information was received (b)(6) 2020.An unknown 0.014 inch guidewire was used during the procedure.The devices had been stored in a storage bin in the cath lab.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 the 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 or Problem Description
Additional information received (b)(6) 2020 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
• Common Device Name: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10078863
• Report Number: 1820334-2020-00974
• Device Sequence Number: 3732022
• Product Code: KGZ
• UDI-Device Identifier: 00827002062993
• UDI-Public: (01)00827002062993(17)241104(10)10126675
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2024
• Device Catalogue Number: PTBYC-RA
• Device Lot Number: 10126675
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 07/22/2020; 07/29/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 07/31/2020; 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1