MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CVL PACK (CVWRF)828; GENERAL SURGERY TRAY (KIT)

Model Number	SAN22CVWRG
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/01/1980
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on supplier investigation, the device history record could not be reviewed as a lot number was not provided.No sample was provided for evaluation, only a photo and video showing lint on the gloves and in bowl.The supplier checked on the retained sample.The average linting data was 0.12g/5 pieces and within limits (=0.38g/10 pieces).The operating room towel is made of cotton, so lint is born and inevitable.The intended use of operating room towel is to be used for applying medication to or absorbing small amounts of body fluids from a patient's body surface.Measures to better control and improve linting have been implemented.A suction process was added before products' final folding and operators perform this activity according to standard operation procedure requirements.In the folding process, one cloth bag protects 100 pieces of semi-finished products to avoid linting stuck onto the products during product transfer.Based on the investigation, all linting test data is within the acceptable range.There is no abnormal situation that has happened in production.Therefore, the root cause could not be determined and no further action.The complaint information was shared with the relevant sectors within the manufacturing facility for their awareness and we will continue to monitor for this type of incident.
Event or Problem Description
The customer reported that the blue, non- x-ray towels 101625 from the central venous line pack/ san22cvwrg were linting and fibers were found on the staff¿s gloves and in a bowl of saline.It was reported that a patient had a stroke.No patient demographics or any clinical data to link the events was provided.

• Brand Name: CVL PACK (CVWRF)828
• 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: 8426201
• Report Number: 1423537-2019-00289
• Device Sequence Number: 11208827
• Product Code: LRO
• UDI-Device Identifier: 10887488869803
• UDI-Public: 10887488869803
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SAN22CVWRG
• Device Catalogue Number: SAN22CVWRG
• Device Lot Number: NONE
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Other