MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH PACK (CBCHQ)840; GENERAL SURGERY TRAY (KIT)

Model Number	SAN11CBCHR
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot number 20190816-23-sh was manufactured on august 16, 2018.No exception was recorded in the device history record that could lead to the reported incident.No sample was available for evaluation.The average linting data is 0.202g / 10 pieces.The linting test data were within the acceptable range, therefore, the root cause could not be determined from this investigation.According to our supplier, or towels are made of cotton, so lint is born and inevitable.We are continuously working to better control the linting and have implemented the following: 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/10 pieces).In the folding process, the supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, however, will continue to monitor the trend of this type of incident.
Event or Problem Description
Based on information received from the customer, reportedly some of the towels have a noticeable abundance of lint.Customer reported no injury to patient.

• Brand Name: CARDIAC CATH PACK (CBCHQ)840
• 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: 9847318
• Report Number: 1423537-2020-00437
• Device Sequence Number: 16823702
• Product Code: LRO
• UDI-Device Identifier: 10888439004267
• UDI-Public: 10888439004267
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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 Expiration Date: 04/01/2023
• Device Model Number: SAN11CBCHR
• Device Catalogue Number: SAN11CBCHR
• Device Lot Number: 369759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Weight: 73