MAUDE Adverse Event Report: DEGANIA MEDICAL DEVICES PVT. LTD MON-A-THERM FOLEY CATHETER WITH TEMPERATURE SENSORMON-A-THERM FOLEY CATHETER; TEMPERATURE SENSING 100% SILICONE FOLEY CATHETER

Model Number 14 FRENCH

Device Problem Low Readings (2460)

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

Event Type  malfunction  

Manufacturer Narrative

This medical device report is filed retrospectively following fda observation number 4 received by degania medical devices pvt.Ltd.During the fda inspection of 4-7 of november 2019.The observation was related to the fact that degania medical devices pvt.Ltd.Did not establish procedures for reporting mdrs to fda as a manufacturer.Till then all complaints related to the devices produced by dmd were assessed for mdr reportability and submitted as necessary to fda by degania silicone ltd.Another q medical devices division closely affiliated with dmd.Dmd capa number (b)(4) was issued to address the observation; one of the capa actions requires dmd to perform retrospective review of all the complaints received during 2018 and 2019 and submit to fda retrospective mdrs for the reportable events (with reference to original reported to fda in the borders of recall activity; report# (b)(4).Incorrect temperature reading was caused by defective sensors, which are purchased component.Degania silicone purchased and assembled the sensors into its silicone catheter.It was explained by the supplier of sensors, that the cracks in defective thermistor tip did not appear immediately but developed following impact of different factors like time, transportation conditions, humidity.This is the reason the inprocess degania tests did not detect the problem.Corrective and preventive action has already been taken at supplier end.Improved control of grinding quality by line leaders and qc staff.Improved visual aids are put on working station.Aql acceptance criteria of incoming sensors will be changed by degania.

Event Description

This is retrospective submission, following reassessment of our customer complaints during period 2018-2019.Customer's text: "according to the reporter, during use, the device provided inaccurate temperature.There was no reported patient outcome".

• Brand Name: MON-A-THERM FOLEY CATHETER WITH TEMPERATURE SENSORMON-A-THERM FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING 100% SILICONE FOLEY CATHETER
• Manufacturer (Section D): DEGANIA MEDICAL DEVICES PVT. LTD; plot no. 251, sector-6,; imt manesar; gurgaon, india 12205 0; IN 122050
• Manufacturer (Section G): DEGANIA MEDICAL DEVICES PVT. LTD.; plot no. 251, sector-6; imt manesar; gurgaon, haryana 12205 0; IN 122050
• Manufacturer Contact: ratnamma nair ; plot no. 251, sector-6; imt manesar; gurgaon, haryana 12205-0 ; IN 122050
• MDR Report Key: 10806355
• MDR Text Key: 247657585
• Report Number: 3005483737-2020-00034
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: 14 FRENCH
• Device Catalogue Number: 102201101480TY
• Device Lot Number: S17007599
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 11/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1