MAUDE Adverse Event Report: CARDINAL HEALTH SHANGHAI TOWEL OR 17X24IN GREEN STERILE 4/PK; FIBER, MEDICAL, ABSORBENT

Model Number	28200-004
Medical Device Problem Codes	Material Discolored (1170); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
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 0.098g/10pcs.There was not a sample returned for investigation.According to supplier, 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 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 100 pieces 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 operating room 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.
Event or Problem Description
Customer reported lint on towel when the towel gets wet.The issue was noted before a coronary angiography procedure.There was no injury noted.
Additional Manufacturer Narrative
Supplemental report is being filed since 4 or towels 28200-004, were returned for investigation.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 0.098g/10pcs.No lint was found on the returned samples.Supplier did suction test for the defected samples and found the linting data is 0.07g/4pcs, which is within the specification (=0.38g/10pieces).A color fastness test was done on the finished product and the water did not change color.Supplier tested the color fastness of the reserved sample and there was no color fading.According to supplier, 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: a.Suction machines have been installed in grey cloth rolling process, dyeing process, and cutting process.B.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.C.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10pieces).D.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.For the color fastness test the finished product was immersed in 38±2°c water with volume of 1400-2000ml.Finished product was rubbed gently 3 times, after 1 minute the water did not change color.From the investigation, there was no abnormal situation in production or device history review.Therefore, the root cause could not be determined.

• Brand Name: TOWEL OR 17X24IN GREEN STERILE 4/PK
• Common Device Name: FIBER, MEDICAL, ABSORBENT
• Manufacturer (Section D): CARDINAL HEALTH SHANGHAI; f20, tower 1, kerry everbright; shanghai 20007 0; CH 200070
• Manufacturer (Section G): CARDINAL HEALTH SHANGHAI; f20, tower 1, kerry everbright; shanghai 20007 0; CH 200070
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 12956800
• Report Number: 1423537-2021-00695
• Device Sequence Number: 20189461
• Product Code: FRL
• UDI-Device Identifier: 10630140917141
• UDI-Public: 10630140917141
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 28200-004
• Device Catalogue Number: 28200-004
• Device Lot Number: 210302-04-SH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown