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 Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer opened a pack of sterile towels, product 28700-004, that reportedly had large pieces of lint on them.The towel was removed from the prep area and not used on the patient.
Additional Manufacturer Narrative
Review of the device history record (dhr) did not indicate any exception that could lead to the reported incident.The average linting data is 0.162g/10pcs.The actual complaint sample was not available for investigation, but photos were provided.Review of the photos revealed a foreign object; however, no abnormal linting can be found.The supplier was unable to confirm the product was linting based on the photos alone.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: 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/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.The investigation revealed no abnormal situation happened in production; therefore, the root cause could not be determined.The complaint information was shared with the relevant sectors for their awareness.There is no action taken at this time, but supplier will continue to monitor the trends for this type of incident.

• 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
• Manufacturer (Section G): JIANERKANG MEDICAL DRESSING CO, LTD; no.1, jian er kang road, zhixi; jiangsu province; jintan city 21325 1; CH 213251
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 13563787
• Report Number: 1423537-2022-00720
• Device Sequence Number: 19297048
• Product Code: FRL
• UDI-Device Identifier: 00630140010142
• UDI-Public: 00630140010142
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2022

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: 28700-004
• Device Catalogue Number: 28700-004
• Device Lot Number: 2000313-16-SH
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/24/2022
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 68 KG