MAUDE Adverse Event Report: DEGANIA SILICONE LTD MON-A-THERM FOLEY CATHETERS WITH TEMPERATURE SENSORS; 2W SIL.FOLEY CATH 12FR W/TEMP.SENSOR

Model Number 12FR

Device Problem Incorrect Measurement (1383)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the unused retain samples from the involved batch and batch history review did not reveal any non-conformity.The complaint considered to be not justified.

Event Description

Degania medical devices pvt, ltd.Received an fda 483 form on november 07, 2019, during an inspection carried out on site (fei #3005483737) from november 04-07, 2019.This mdr is retrospective report made following review of customer complaints received by degania silicone during 2018-2019.This retrospective review was one of the actions of capa # (b)(4) issued for obs#3 of the received 483 form.Issue description: according to the reporter, during use of the device, the device's temperature monitoring did not work.It was reported that they have swapped catheters in four cases.There was no reported patient outcome.

• Brand Name: MON-A-THERM FOLEY CATHETERS WITH TEMPERATURE SENSORS
• Type of Device: 2W SIL.FOLEY CATH 12FR W/TEMP.SENSOR
• Manufacturer (Section D): DEGANIA SILICONE LTD; degania bet; degania bet, 15130 00; IS 1513000
• Manufacturer (Section G): DEGANIA SILICONE LTD; degania bet; degania bet, 15130 00; IS 1513000
• Manufacturer Contact: katia kayam ; degania bet; degania bet, jordan valley 15130-00 ; IS 1513000
• MDR Report Key: 10470328
• MDR Text Key: 204937217
• Report Number: 8030107-2020-00021
• Device Sequence Number: 1
• Product Code: EYB
• 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: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2022
• Device Model Number: 12FR
• Device Catalogue Number: 102201101280TY
• Device Lot Number: S17004479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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