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	05/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a pulmonary vein isolation case, the nurse that was scrubbing in noticed right away when drying her hands that the towels had excessive lint and fabric particles.There was no harm to the patient.
Additional Manufacturer Narrative
Based on supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident.The average linting data is 0.105g/10pcs.There was no sample available for investigation.According to supplier, or towel is made of cotton, so cotton fiber is born.Supplier continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suction machines have been installed in the grey cloth rolling process, dyeing process, and cutting process.The suction process was added before product's final folding, and workers process 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 lint from being stuck onto the product 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.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, supplier will continue to monitor the trend of this type of incident.

• 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): JIANERKANG MEDICAL CO., LTD.; no.1 jianerkang road, zhixi to; zhixi town industrial zone, ji; changzhou city, jiangsu provin ; CH
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 14676133
• Report Number: 1423537-2022-00785
• Device Sequence Number: 12033065
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2022

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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/27/2022
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 06/13/2022
• 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: Female