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

Model Number 28700-004

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

Based on the device history record, lot number 190812-16-sh was manufactured on 8/29/2019.No exception was recorded in the device history record that could lead to the reported incident.The average linting data is 0.210 g / 10 pieces.No physical sample was provided; however, photos were provided.Blue lint was noted on photo.From the investigation, there is no abnormal situation which happened during production.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, however, the supplier will continue to monitor the trend of this type of incident.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: 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.(=0.38 g/10 pieces).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.

Event Description

Cath lab is reportedly experiencing blue lint coming off the blue or towels.It is a single sterile towel pack.

• Brand Name: TOWEL OR 17X24IN BLUE STERILE 4/PK
• Type of Device: FIBER, MEDICAL, ABSORBENT
• Manufacturer (Section D): JIANERKANG MEDICAL DRESSING CO. LTD.; no. 1 jian er kang road, zhixi; jiangsu province; jintan city 21325 1; CH 213251
• 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 ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 10211637
• MDR Text Key: 198119795
• Report Number: 1423537-2020-00473
• Device Sequence Number: 1
• Product Code: FRL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28700-004
• Device Catalogue Number: 28700-004
• Device Lot Number: 190812-16-SH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2020
• Type of Device Usage: N
• Patient Sequence Number: 1