MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE KIT, OPEN HEART SET UP (HNOJ )744; CARDIOVASCULAR PROCEDURE KIT

Model Number	PC24OHNOJ
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, device history record (dhr) could not be reviewed as lot number was not provided.However, supplier reviewed the record in the last 2 years, no abnormal situation was found.No sample was available for investigation.According to the supplier, the operating room towel is made of cotton, so cotton fiber is born.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.(b)(4).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, no abnormal situation 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 supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported excessive linting of the blue or towels pwtb04-stm from the open heart setup kit pc24ohnoj.The towels were immediately removed and replaced after the linting was noticed.No injury reported.No further information was provided when asked.Report being filed for potential risk.

• Brand Name: KIT, OPEN HEART SET UP (HNOJ )744
• 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: 11773250
• Report Number: 1423537-2021-00631
• Device Sequence Number: 19867947
• Product Code: OEZ
• UDI-Device Identifier: 10888439181975
• UDI-Public: 10888439181975
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 05/04/2021

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: PC24OHNOJ
• Device Catalogue Number: PC24OHNOJ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 05/04/2021
• 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