MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE NEURO ANGIO PACK 687; GENERAL SURGERY TRAY (KIT)

Model Number	SNE40NACFA
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot#20190802-23-sh was manufactured on 02nd aug 2019.Based on supplier investigation, device history record review did not indicate any exception that could lead to the reported incident.The average linting data is 0.207g / 10 pieces.No sample was available for investigation.According to supplier, or towel is made of cotton, so cotton fiber is born and inevitable.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/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.From the investigation, there is no abnormal situation happened in 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, but supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
The customer reported excessive amount of lint coming off of the blue surgical towels pwtb04-stm from the neuro angiography pack sne40nacfa during a carotid stent placement.The towels were used to drape over the patient and layered to cover the drip lines.Several pauses were needed to clean the lint from gloves, catheters, instruments and saline bowl.There was no patient injury.No patient demographics were provided when inquired.The event date was unknown by the customer.Cardinal health is filing an mdr for potential risk to patient.

• Brand Name: NEURO ANGIO PACK 687
• Common Device Name: GENERAL SURGERY TRAY (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: 9759123
• Report Number: 1423537-2020-00428
• Device Sequence Number: 16939670
• Product Code: LRO
• UDI-Device Identifier: 10888439572568
• UDI-Public: 10888439572568
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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: Health Professional
• Device Model Number: SNE40NACFA
• Device Catalogue Number: SNE40NACFA
• Device Lot Number: 331887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1