MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC CATH LAB TRAY (CLKFJ)245; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SAN3BCLK11
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review did not indicate any exception that could lead to the reported incident.No sample was available for investigation.Five photos were provided.Four were of used surgical towels and one was of a device with blood.There were no abnormalities found on the towel.According to supplier, the blue or towel is made of cotton, so cotton fiber is born.The supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suction machines have been installed in grey cloth rolling process, dyeing process, and cutting process.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10pieces).In the folding process, supplier used one cloth pad under 100pieces semi-finished products to avoid linting stuck onto the products during product's transfer.Based on the investigation, there were no abnormalities found during production of the or towels; therefore, the root cause could not be determined.We will continue to monitor trends for this type of incident.
Event or Problem Description
Customer reported an abundance of lint from the blue cotton or towels pwtb04-stm, from the san3bclk11 cath lab tray.Lint was found in the coronary arteries and removed successfully with no injury or adverse effect to the patient.

• Brand Name: CATH LAB TRAY (CLKFJ)245
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC; 3651 birchwood dr; waukegan IL 60085
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 15818159
• Report Number: 1423537-2022-00859
• Device Sequence Number: 7028006
• Product Code: OEQ
• UDI-Device Identifier: 10195594459376
• UDI-Public: 10195594459376
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2022

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 Model Number: SAN3BCLK11
• Device Catalogue Number: SAN3BCLK11
• Device Lot Number: 730257
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/17/2022
• Date Device Manufactured: 11/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male