MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH (CCAMJ)163; GENERAL SURGERY TRAY (KIT)

Model Number	SAN23CCAMK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot number f94378 was manufactured from 26th feb to 02nd mar 2020.No exception was recorded in the device history record that could lead to the reported incident.A review of the device history record for recent 12 months, no abnormalities were found.No sample was available for this investigation.According to supplier, the or towel is made of cotton.The suction process was performed before product final folding, and operators do it according to standard operation procedure (sop) requirements.Linting test method and acceptable criteria was stipulated to see the suction results (=0.38 g/10 pieces).They checked their retained sample, the linting test result is 0.112 g / 5 pieces.From the investigation, there were no abnormalities found in production and all linting test data were within the acceptable range.Therefore, the root cause could not be determined.There is no action taken at this time, however, we will continue to monitor the trend of this type of incident.
Event or Problem Description
Based on information received by the customer, lint from our or towels was reportedly drawn up in the flush syringe.There was no injury to the patient, the lint was found prior to affecting the patient.

• Brand Name: CARDIAC CATH (CCAMJ)163
• 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: 10629854
• Report Number: 1423537-2020-00536
• Device Sequence Number: 16836002
• Product Code: LRO
• UDI-Device Identifier: 00885425856582
• UDI-Public: 00885425856582
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/05/2020

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: SAN23CCAMK
• Device Catalogue Number: SAN23CCAMK
• Device Lot Number: 448209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other