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

Model Number	28700-004
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
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 0.158g/10pcs.No sample was available for investigation, but photos and a video were provided.Photos showed that blue lint was found on gloves.Video showed a little lint adhered to the gloves after the doctor rubbed the towel.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: suctions 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/(b)(4)).In the folding process, supplier used one cloth pad under (b)(4) semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, there was nothing abnormal during production or in the device history record.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, but supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported a concern with the or towels.She stated that when the towels are wet, they shed fibers onto their sterile gloves.She noticed it initially when she was unable to push a wire through a catheter because it was being stopped by the fibers that had flaked off into the bowl that they soak their wires in.She is concerned that more of these fibers could have gotten onto devices or into patients.According to the customer, the procedure may have been an embolization, where groin access was used.There was no injury reported.

• Brand Name: TOWEL OR 17X24IN BLUE 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
• MDR Report Key: 12333419
• Report Number: 1423537-2021-00663
• Device Sequence Number: 2695885
• Product Code: FRL
• UDI-Device Identifier: 00630140010142
• UDI-Public: 00630140010142
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

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: No Information
• Device Model Number: 28700-004
• Device Catalogue Number: 28700-004
• Device Lot Number: 201109-16-SH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/17/2021
• Patient Sequence Number: 1