MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE HUMC LEFT HEART KIT (LHHMI)115; GENERAL SURGERY TRAY (KIT)

Model Number	SAN11LHHMJ
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot number 20190511-23-sh was manufactured on 23rd may 2019.No exception was recorded in the device history record that could lead to the reported incident.No sample was provided for investigation.The average linting data is 0.142g / 10 pieces.According to our supplier, the or towel is made of cotton, so lint is born and inevitable.Our supplier is continuously working with (b)(4) to better control the linting and have implemented several measures to improve it: 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.Based on the investigation, all linting test data was within the acceptable range.There was no abnormal situation that had happened in production.Therefore, the root cause could not be determined and no further action taken.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
Customer reported the towels are creating to much lint.

• Brand Name: HUMC LEFT HEART KIT (LHHMI)115
• 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: 9177557
• Report Number: 1423537-2019-00355
• Device Sequence Number: 2230571
• Product Code: LRO
• UDI-Device Identifier: 10887488833620
• UDI-Public: 10887488833620
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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: SAN11LHHMJ
• Device Catalogue Number: SAN11LHHMJ
• Device Lot Number: 270350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/10/2019
• Patient Sequence Number: 1