MAUDE Adverse Event Report: DEGANIA SILICONE LTD MON-A-THERM FOLEY CATHETERS WITH TEMPERATURE SENSORS; MON-A-THERM¿ FOLEY CATHETER 12FR BLUE TIP F400 WITH TEMPERATURE SENSOR

Model Number 12FR

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/06/2018

Event Type  malfunction  

Manufacturer Narrative

The actual sample was unavailable for our evaluation.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 any manufacturing failure, therefore no corrective action is required in this case.

Event Description

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.However no pain or bleeding from the urethra/bladder.Poor amount of urine and regular bladderscan does not indicate any resudual urine.The patient was in a palliative state and it is deemed not appropriate for further action to remove the broken piece.On 29/11/18 we received the next update: it was reported that the patient died on (b)(6) 2018, which the provider states was unrelated to the device and event.The patient was (b)(6) years of age, (b)(6) kg, with a medical history of a-fib without anticoagulation therapy per patient's decision, heart failure, a tumor treated with radiation, and an unnamed skin condition being treated with methotrexate.The patient was reported to be "treated on the ward after taking a fall at home and was hypothermic had bradykardia (hr 28/min, t: 30° c)".

• Brand Name: MON-A-THERM FOLEY CATHETERS WITH TEMPERATURE SENSORS
• Type of Device: MON-A-THERM¿ FOLEY CATHETER 12FR BLUE TIP F400 WITH TEMPERATURE 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: 9368488
• MDR Text Key: 205171654
• Report Number: 8030107-2019-00021
• 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: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: 12FR
• Device Catalogue Number: 102201101280TY
• Device Lot Number: S18006674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 92 YR
• Patient Weight: 97