MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE OPEN HEART 747; CARDIOVASCULAR PROCEDURE KIT

Model Number	SCV21OPHVA
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, device history record could not be reviewed as lot number was not provided.However, supplier reviewed their records for the last 2 years and no abnormal situation was found.No sample was available at the time of investigation.  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.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.Based on the investigation, there were no abnormalities found during production of the or towels; therefore, the root cause could not be determined.The complaint information was shared with the relevant sectors for their awareness.No action taken at this time, but the supplier will continue to monitor trends for this type of incident.
Event or Problem Description
Cardio-vascular surgeon was upset about the or towels (pwtb04-stm) in new open heart packs (scv21ophva).He reported that the towels were unacceptable as they had an excessive amount of lint.The lint was found on towels, instruments, patient, scrub personnel, on doctor hands, and surgeons gloves, as well as, in the aortic leaflets.There was no patient injury.No patient demographics provided upon request.

• Brand Name: OPEN HEART 747
• 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: 11310969
• Report Number: 1423537-2021-00592
• Device Sequence Number: 3132214
• Product Code: OEZ
• UDI-Device Identifier: 10888439690965
• UDI-Public: 10888439690965
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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: SCV21OPHVA
• Device Catalogue Number: SCV21OPHVA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/10/2021
• Patient Sequence Number: 1