MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CHI STD OPEN HEART BASIC OPT 7 702; CARDIOVASCULAR PROCEDURE KIT

Model Number	CHIP99OH7D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record for lot number 20200213-23-sh revealed it was manufactured on january 07th 2020.Based on supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident.The average linting data is 0.162 g / 10 pieces.No sample was returned for investigation.According to supplier, or towel is made of cotton, so cotton fiber is born.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.(=0.38 g/10 pieces).In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.The investigation revealed there was no abnormal situation that happened during production; therefore, the root cause could not be determined.The complaint information was shared with the relevant sectors for their awareness.There is no action taken at this time, but the supplier will continue to monitor trends for this type of incident.
Event or Problem Description
Customer reported more lint then normal from blue towels in the open heart basic pack during aortic valve replacement procedure.

• Brand Name: CHI STD OPEN HEART BASIC OPT 7 702
• Common Device Name: CARDIOVASCULAR PROCEDURE 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: 10364710
• Report Number: 1423537-2020-00496
• Device Sequence Number: 11543782
• Product Code: OEZ
• UDI-Device Identifier: 10888439008050
• UDI-Public: 10888439008050
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2020

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: CHIP99OH7D
• Device Catalogue Number: CHIP99OH7D
• Device Lot Number: 403553
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 08/04/2020
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 93