MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CCL PACK LG 933; ORTHOPEDIC TRAY

Model Number	SOPCGCPLGA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, device history record review was not able to be reviewed as lot number was not provided.Supplier reviewed records in the last 2 years and no abnormal situation was found.There was no sample available for investigation.According to supplier, or 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.(=0.38g/10pieces).In the folding process, supplier used one cloth pad under 100pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, there was nothing abnormal during production or in the device history record.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 linting of the or towels pwtb04-stm from the cardiac catheterization lab pack sopcgcplga during cardiac cath/percutaneous coronary intervention procedures.The customer could not pinpoint the number of times linting was found during procedures.Customer confirmed there was no adverse effect or injury to any patients.No patient demographics or further information was provided when requested.Mdr is being filed for risk to patient.

• Brand Name: CCL PACK LG 933
• Common Device Name: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 12470767
• Report Number: 1423537-2021-00673
• Device Sequence Number: 11585327
• Product Code: OJH
• UDI-Device Identifier: 10888439636680
• UDI-Public: 10888439636680
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2021

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: SOPCGCPLGA
• Device Catalogue Number: SOPCGCPLGA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/14/2021
• Patient Sequence Number: 1