MAUDE Adverse Event Report: COOK INC TRIFORCE PERIPHERAL CROSSING SET; KRA CATHETER, CONTINUOUS FLUSH

Model Number G56417

Device Problem Crack (1135)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

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 an unknown procedure, a triforce peripheral crossing set was used to cross a venous lesion.The inner cxi catheter was removed, leaving an unknown wire guide in place.The user flushed through the side port of the outer catheter and the hub cracked, leaving a small piece in the syringe.The inner catheter was used to complete the procedure with no issues.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Description of event: as reported, during an unknown procedure, a triforce peripheral crossing set was used to cross a venous lesion.The inner cxi catheter was removed, leaving an unknown wire guide in place.The user flushed through the side port of the outer catheter and the hub cracked with heparinized saline, leaving a small piece in the syringe.The inner catheter was used to complete the procedure with no issues.The procedure was completed successfully.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, and quality control data.One used device was returned for investigation with biomatter present.Inspection found that the luer fitting on the side of check flo was cracked.No other was damage noted.Cook concluded that the device was manufactured within specification.A review of the device history record found no non-conformances related to the reported failure mode.Because 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 review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded a component failure contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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 new patient or event information to report.

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 Description

Additional information was received 11feb2021.The hub was reportedly wiped down with heparinized saline.The procedure was completed successfully.

• Brand Name: TRIFORCE PERIPHERAL CROSSING SET
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11259472
• MDR Text Key: 230176750
• Report Number: 1820334-2021-00217
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002564176
• UDI-Public: (01)00827002564176(17)220808(10)9810964
• Combination Product (y/n): N
• PMA/PMN Number: K170931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2022
• Device Model Number: G56417
• Device Catalogue Number: KCXS-5.0-35-100-RB-0/DAV-HC
• Device Lot Number: 9810964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1