MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE OPEN HEART PACK DRP SH 36883 (ODSNC)654; CARDIOVASCULAR PROCEDURE KIT

Model Number SCVHDODSNC

Device Problems Material Separation (1562); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.

Event Description

Customer reported that during a coronary artery bypass graft procedure, a piece of lint was found on the towel pwtb04-stm from the open heart pack scvhdodsnc.Towel used for holding instruments.There was no injury to the patient.

Manufacturer Narrative

Supplemental report is being filed since the results of investigation are available.From the device history record, lot# 20210120-23-sh was finished on 26th jan 2021.No exception was recorded in the device history record that could lead to the reported incident.Based on supplier investigation, device history record (dhr) review did not indicate any exception that could lead to the reported incident.Supplier checked on their retained sample, the sample is intact without any lint on it.No physical sample was available for investigation.A photo was provided showing blue lint on the towel.According to the supplier, before production operation, the staff shall clean the equipment according to requirements and clean the lint on the equipment before operation.Supplier performed suction after the sewing, which can remove the foreign matters on the towel.The workers also do the visual test for every piece of product when folding.The lint in the complaint photo can be removed by employees, and it can also be removed in the suction process.In the folding process, supplier used one cloth pad under 100 pcs semi-finished products to avoid linting stuck onto the products during products' transfer.In the production process, employees clean the worktable every 2 hours.The foreign matter is always being controlled as a main defect factor.The process sampling criteria is aql:0.25.For the final product, it is i, aql:0.65.They checked the dhr, no record of foreign matter was found.Supplier confirmed this is an isolated incident and the root cause cannot be determined.

• Brand Name: OPEN HEART PACK DRP SH 36883 (ODSNC)654
• Type of Device: CARDIOVASCULAR PROCEDURE 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: 12211253
• MDR Text Key: 265139134
• Report Number: 1423537-2021-00655
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 10887488787343
• UDI-Public: 10887488787343
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCVHDODSNC
• Device Catalogue Number: SCVHDODSNC
• Device Lot Number: 629280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other