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

Model Number PVCGOHCOB

Device Problem Material Frayed (1262)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2020

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 10861492
• MDR Text Key: 218246531
• Report Number: 1423537-2020-00562
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10888439839852
• UDI-Public: 10888439839852
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PVCGOHCOB
• Device Catalogue Number: PVCGOHCOB
• Device Lot Number: 468450
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other