MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CATH LAB PACK (CLHDE)386; GENERAL SURGERY TRAY (KIT)

Model Number	SAN44CLHDF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot number 11sf02-sh, no exception was recorded in the device history record that could lead to the reported incident.No sample was returned for investigation, only photo was provided.There was a small pile of fuzz noted in photo.Supplier performed an investigation on their processes.It was found that a few operators in washing workshop did not strictly follow the operation instructions.In order to save time, the product was put into the washing machine with multiple pieces ground together for washing, resulting in not fully being unfolded and linting was not completely cleared.After observation, they found the phenomenon was occasional.In terms of inspection for linting, they always keep the inspection rule: linting weight for every 10 pieces of or towel =0.38g and the test results were within allowable range.The following corrective/preventative measures were taken: 1) retraining was conducted to all the workers in washing workshop as they must strictly follow the specified operation procedures.2) they have to spray or towels into washing machine piece by piece.3) quality coordinator inspector will do random inspection for washing or towels in the workshop.
Event or Problem Description
Based on information received from the customer, the blue towels in the packs are allegedly leaving behind blue lint.The concern is that the lint has been found on the wires that are inserted into the arterial system.(left catheterization) per the customer there was no injury to patient.

• Brand Name: CATH LAB PACK (CLHDE)386
• 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: 10042596
• Report Number: 1423537-2020-00453
• Device Sequence Number: 2917124
• Product Code: LRO
• UDI-Device Identifier: 10887488933528
• UDI-Public: 10887488933528
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/11/2020

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: SAN44CLHDF
• Device Catalogue Number: SAN44CLHDF
• Device Lot Number: 366599
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 05/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other