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 12 FRENCH

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Death (1802); Foreign Body In Patient (2687)

Event Date 10/16/2018

Event Type  Death  

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 8030107-2019-00021 report filed by degania silicone ltd.) the customer indicated that the catheter broke following "worrying movement patterns" of the patient who is in palliative state.The breakage did not happen following aby manufacturing failure; therefore no corrective action is required in this case.

Event Description

This is retrospective submission, following re-assessment of our customer complaints during period 2018-2019.Customer's text: according to the reporter, during a normal use, the patient had worrying movement patterns, which moved the catheter, and broke.It was reported that 10 to 15 cm of the catheter was still in the urethra or bladder.The patient was in a palliative state, and it is deemed not appropriate for further action.On 29/11/18 the customer updated us that the patient has died.The catheter breakage was confirmed to be caused by patient's condition, and the death was confirmed not to be related to the device of degania (the patient was at terminal state).

• 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: 10776286
• MDR Text Key: 214303505
• Report Number: 3005483737-2020-00026
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2023
• Device Model Number: 12 FRENCH
• Device Catalogue Number: 102201101280TY
• Device Lot Number: S18006674
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2019
• Initial Date FDA Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2018
• 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
• Patient Outcome(s): Hospitalization