MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CATH LAB PACK (CLKSC)672; GENERAL SURGERY TRAY (KIT)

Model Number	SAN69CLKSD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, device history record could not able to be reviewed as lot number provided was incorrect.At the time of this investigation no sample has been returned.From the investigation, there is no abnormal situation has happened during production.Therefore, the root cause could not be determined.The complaint information was provided to the relevant sectors for their awareness.There is no action taken at this time, however, we will continue to monitor the trend of this type of incident.According to our supplier, or towels are made of cotton, so lint is born and inevitable.The supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: 1) suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.2) the suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.3) besides, linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10 pieces).4) in the folding process, the supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.
Event or Problem Description
Based on information received from the customer, allegedly, when trying to remove the clot, it appeared something was getting stuck on the catheter.Reportedly the clot was aspirated out and upon inspection it seemingly appeared to be a piece of blue lint from one of the towels commonly used in the procedure, was part of the clot.The entire clot was removed, there was no other clot visible in the patient artery.Patient had no chest pain and st elevation resolve.No further information was provided by the customer.

• Brand Name: CATH LAB PACK (CLKSC)672
• 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: 8926923
• Report Number: 1423537-2019-00339
• Device Sequence Number: 2206470
• Product Code: LRO
• UDI-Device Identifier: 10887488754642
• UDI-Public: 10887488754642
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SAN69CLKSD
• Device Catalogue Number: SAN69CLKSD
• Device Lot Number: 255890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other