MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE LEFT HEART KIT (LHKCE)749; GENERAL SURGERY TRAY (KIT)

Model Number	SCV73LHKCF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot number 20190527-23-sh was manufactured on 03rd june 2019.No exception was recorded in the device history record that could lead to the reported incident.No sample was available for investigation, only a photo of some lint found on the surface of the product was provided.The lint did not appear to be loose, it appeared to be attached to the yarn.The linting test data was within the acceptable range, therefore the root cause could not be determined for this reported issue.According to our supplier, or towels are made of cotton, so lint is born and inevitable.The supplier is continuously working with cardinal health 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.
Event or Problem Description
Based on the customers account, there was reportedly excess lint on the or towels.There was manual removal, wipe down and flush.

• Brand Name: LEFT HEART KIT (LHKCE)749
• 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: 9202034
• Report Number: 1423537-2019-00353
• Device Sequence Number: 2424349
• Product Code: LRO
• UDI-Device Identifier: 10888439389630
• UDI-Public: 10888439389630
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SCV73LHKCF
• Device Catalogue Number: SCV73LHKCF
• Device Lot Number: 276679
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Weight: 82