MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH TRAY (CTSRF)602; GENERAL SURGERY TRAY (KIT)

Model Number	SCVOCCTSRG
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of this investigation the device history record could not be verified, as a lot number was not provided.Based on the supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident.A sample was not provided for evaluation, but our blue or towel is classified as a ¿low lint cotton or towel¿ and since the towel is made of cotton, some lint is inevitable.Our 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 has been added before the product's final folding, and workers do it according to standard operation procedure requirement.Linting test method and acceptable criteria has been stipulated to see the suction results.(=0.38g/10pieces).In the folding process, our supplier uses one cloth pad under 100 pieces semi-finished products to avoid linting being stuck onto the products during product's transfer.Based on the investigation, there is no abnormal situation noted that may have happened in production and all linting test data were within the acceptable range.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no other action taken at this time, however, our supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
The customer stated that the blue,cotton, non-x-ray towels, component pwtb03-stma from catalog scvocctsrg /cardiac catheterization pack, were linting.The physician used the dry towel to rest his wires on (not wiping the wires) and noticed that when he went to use the wire there was lint from the blue towel adhering to the wire.No injury was reported.No patient demographics or date of event were provided.Mdr being filed for potential risk to the patient.

• Brand Name: CARDIAC CATH TRAY (CTSRF)602
• 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: 9168723
• Report Number: 1423537-2019-00352
• Device Sequence Number: 2403470
• Product Code: LRO
• UDI-Device Identifier: 10887488768809
• UDI-Public: 10887488768809
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

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: SCVOCCTSRG
• Device Catalogue Number: SCVOCCTSRG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/08/2019
• 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