MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CORONARY ANGIO DRAPE CMC (CAACA)933; CARDIOVASCULAR PROCEDURE KIT

Model Number	SANCGCAACA
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, device history record could not be reviewed because the lot number was not provided.However, the supplier reviewed records in the last two years and did not find anything abnormal.No sample returned for investigation, but photos were provided.Review of photos provided revealed lint was found.According to the 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.(=0.38g/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.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 supplier will continue to monitor trends for this type of incident.
Event or Problem Description
Customer reported linting from or towel.No additional information or patient demographics provided.

• Brand Name: CORONARY ANGIO DRAPE CMC (CAACA)933
• 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: 10523100
• Report Number: 1423537-2020-00516
• Device Sequence Number: 2591164
• Product Code: OEZ
• UDI-Device Identifier: 10888439647228
• UDI-Public: 10888439647228
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/11/2020

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: SANCGCAACA
• Device Catalogue Number: SANCGCAACA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/11/2020
• Patient Sequence Number: 1