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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, the device history record could not be reviewed as a lot number was not provided.However, the supplier reviewed the record in the last 2 years and no abnormal situation was found.There are 169 occurrences reported in the past 12 months.No sample was available for investigation, only photos were provided.Lint was found on the surface of the product.According to supplier, operating room towel is made of cotton, so cotton fiber is born.Supplier continuously is 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, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, there is no abnormal situation that happened in production.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but the supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported that high lint levels from the operating room towels pwtb04-stm in the open hear basic pack chip99oh7d were found on staff¿s hands and instruments during a coronary artery bypass graft, cabg, procedure.There was no patient injury.Report being filed for risk.

• 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: 10480243
• Report Number: 1423537-2020-00508
• Device Sequence Number: 2793536
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Weight: 67