MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE STEWARD ROCKLEDGE CATH RRS PK (CLWHE)180; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SANHFCLWHE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, a review of the device history record (dhr) revealed no indication any exception was recorded that could lead to the reported incident.The lot#20191113-23-sh reported revealed the product was manufactured on november 15, 2019.The average linting data is 0.162 g / 10 pieces.No sample was returned at the time of the 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: 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 during 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 trend for this type of incident.
Event or Problem Description
The customer reported noticing visible lint on the towels a couple of weeks ago.The lint has gotten on devices, gloves, drapes - anything the towels touch.No patient demographics provided.

• Brand Name: STEWARD ROCKLEDGE CATH RRS PK (CLWHE)180
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 10748416
• Report Number: 1423537-2020-00557
• Device Sequence Number: 14254174
• Product Code: OEQ
• UDI-Device Identifier: 10888439643848
• UDI-Public: 10888439643848
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: SANHFCLWHE
• Device Catalogue Number: SANHFCLWHE
• Device Lot Number: 471382
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1