MAUDE Adverse Event Report: DEGANIA MEDICAL DEVICES PVT. LTD TEMPERATURE SENSING CATHETER; TEMPERATURE SENSOR CATHETER

Model Number 16 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 73/19 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.Upon inspection of the unused samples from the complained lots and also one actual used sample which is showed incorrect temperature, we were unable to confirm the problem in catheters.All the measurement were conforming to the specification.

Event Description

This is retrospective submission, following reassessment of our customer complaints during period 2018-2019.Customer's text: according to the reporter, the unit had 8-10 foley catheters were used, 16fr, and were all providing wrong temperature measurements: ie in one case the measurement of the patient's temperature was displayed as 40 degrees c for 4 days whereas his temperature has never reached that level as measured by other means of measurements and after the first 24 h he had no fever.In another case, the measurement was displayed for a few seconds and then disappeared from the monitor.We personally witnessed these events in order to verify the claim.We cannot be certain as per above if this is an issue of the sensor or the cable.The hospital is going to investigate the possibility of a problem on the monitor's temperature module but this means that all their monitors are broken and it is not probable".

• Brand Name: TEMPERATURE SENSING CATHETER
• Type of Device: TEMPERATURE SENSOR 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: 10798611
• MDR Text Key: 227878797
• Report Number: 3005483737-2020-00030
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16 FRENCH
• Device Catalogue Number: 102201101663BI
• Device Lot Number: V18028029
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2018
• 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