MAUDE Adverse Event Report: JIANERKANG MEDICAL CO LTD TOWEL OR 17X24IN GREEN STERILE 4/PK; FIBER, MEDICAL, ABSORBENT

Model Number	28200-004
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, device history record (dhr) review for lot# 210504-04-sh did not indicate any exception that could lead to the reported incident.The average linting data is 0.178g/10pcs no sample was available for investigation.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: 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); 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, no abnormal situation happened in production or dhr.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 during a cardiac surgery, lint residue was left on the skin of the patient when trying to remove the excess chlorexidine used to disinfect skin of patient.There was no adverse event or injury.
Additional Manufacturer Narrative
Supplemental report being filed following the initial mdr report 1423537-2021-00703, since the device sample was received for evaluation.From the device history record (dhr) of lot #210504-04-sh, no exception was recorded in the device history record that could lead to the reported incident.4 pieces of samples were returned for investigation.Visual test and suction test were conducted.No lint was found.The linting data is 0.07g/4pcs.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: suction machines have been installed in grey cloth rolling and dyeing and cutting process, the suction process was added before product's final folding per 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.The complaint information was informed to the relevant sectors for their awareness.We will continue to monitor the trend of this type of incident.

• Brand Name: TOWEL OR 17X24IN GREEN STERILE 4/PK
• Common Device Name: FIBER, MEDICAL, ABSORBENT
• Manufacturer (Section D): JIANERKANG MEDICAL CO LTD; no.1 jianerkang road, zhixi; jiangsu province; changzhou city 21325 1; CH 213251
• Manufacturer (Section G): JIANERKANG MEDICAL CO LTD; no.1 jianerkang road, zhixi; jiangsu province; changzhou city 21325 1; CH 213251
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 13065097
• Report Number: 1423537-2021-00703
• Device Sequence Number: 6010057
• Product Code: FRL
• UDI-Device Identifier: 50630140010031
• UDI-Public: 50630140010031
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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: 210504-04-SH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/30/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 06/27/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown