MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC TOWEL OR BLUE STERILE; FIBER, MEDICAL, ABSORBENT

Model Number	28700-006
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the or towels were disintegrating after getting wet in the sterile saline in the sterile bowls, during a watchman left atrial appendage occlusion device procedure.Fuzzy type pieces were coming off.There was no harm to the patient.
Additional Manufacturer Narrative
Based on supplier investigation, device history record (dhr) review did not indicate any exception that could lead to the reported incident.The average linting data is 0.105g/10pcs.A sample was not returned for investigation.According to supplier, the or towel is made of cotton, so cotton fiber is born.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), and in the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, there is no abnormal situation happened in production or dhr.Therefore, the root cause could not be determined.Cardinal will continue to monitor trends for this product.

• Brand Name: TOWEL OR BLUE STERILE
• Common Device Name: FIBER, MEDICAL, ABSORBENT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood dr; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH SHANGHAI; f20, tower 1, kerry everbright; shanghai 20007 0; CH 200070
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 14739144
• Report Number: 1423537-2022-00792
• Device Sequence Number: 12174617
• Product Code: FRL
• UDI-Device Identifier: 10630140917257
• UDI-Public: 10630140917257
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2022

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: 28700-006
• Device Catalogue Number: 28700-006
• Device Lot Number: 220106-18-SH
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/24/2022
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/17/2022
• Date Device Manufactured: 01/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male