MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CVL PACK (CVWRG)612; GENERAL SURGERY TRAY (KIT)

Model Number	SAN22CVWRG
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the supplier investigation, the device history record could not be reviewed as lot number was not provided.The supplier reviewed records over the last 2 years and no abnormal situation was found.No sample was available for investigation.According to the supplier, the or towel is made of cotton, so cotton fiber is born and inevitable.The suppliers are continuously working with cardinal health to better control the linting and have implemented several measures to improve it: a.Suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.B.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.C.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10 pieces).D.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 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
The customer reported linting of the blue, non-x-ray cotton towels pwtb04-stm from the cardiovascular pack san22cvwrg.The procedure that was performed was a cardiac catheterization.There was no apparent injury or negative patient outcome during the procedure, only a delay to change gloves, remove towels and empty fluid containers.No patient demographics were provided when asked.Although there was no injury, cardinal health is filing a medwatch report for potential risk to the patient.

• Brand Name: CVL PACK (CVWRG)612
• Common Device Name: GENERAL SURGERY TRAY (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: 9672718
• Report Number: 1423537-2020-00407
• Device Sequence Number: 14025501
• Product Code: LRO
• UDI-Device Identifier: 10887488869803
• UDI-Public: 10887488869803
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/05/2020

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: SAN22CVWRG
• Device Catalogue Number: SAN22CVWRG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 02/05/2020
• 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