MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE KIT,OPEN HEART CON (HCOA )933; GENERAL SURGERY TRAY (KIT)

Model Number	PVCGOHCOB
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot number 190430100sh was manufactured from 13th mar to 18th mar 2019.No exception was recorded in the device history record that could lead to the reported incident.Sample not sent to plant due to covid-19, only photos were provided.Supplier observed that the x-ray filament in the photos looks very straight, while the x-ray filament in their actual product is twisted.Therefore, supplier confirmed that the sample in the photos does not belong to them.Supplier checked the operation of workers, and they are within compliance with the standard of operation (sop) of gauze swab production.Therefore, the root cause could not be determined.There is no action taken at this time, however, we will continue to monitor the trend of this type of incident.
Event or Problem Description
Based on information received by the customer, the raytec sponges in the custom pack are reportedly fraying and the sponges cannot be used.

• Brand Name: KIT,OPEN HEART CON (HCOA )933
• 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: 10861492
• Report Number: 1423537-2020-00562
• Device Sequence Number: 19500929
• Product Code: LRO
• UDI-Device Identifier: 10888439839852
• UDI-Public: 10888439839852
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

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: No Information
• Device Model Number: PVCGOHCOB
• Device Catalogue Number: PVCGOHCOB
• Device Lot Number: 468450
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other