MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT 100% SIL FOLEY 1.5ML PED

Catalog Number 170003-000060

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fever (1858); Pain (1994)

Event Date 02/15/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the patient is a new born baby (b)(6) kg male.The baby needed another intubation.Nurses inserted the catheter but when they were going to attach the catheter they noticed there was a leak drop by drop of urine in the baby's diaper at the place where the catheter was inserted, approximately at the middle of the device.So , they removed this catheter.Please note that for this device, they had controlled the packaging, tested the balloon, and then connected the catheter to the collecting bag.A second catheter was inserted but it has been extremely painful for the patient.Patient had a fever the night after , but we cannot be sure if it was due to an infectious cause because of the catheter or any other cause.This baby was fragile because he also had a cvc inserted.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed all qa inspections.Above complaint stated there is a leak catheter on the outside of the patient body, the leak was observed by nurse as "drop by drop urine in the baby diaper".The device was controlled and pre-tested prior use suggesting the device function as it intended to be use.Catheter leak may happen due to in contact with sharp object or mishandling during catheterization.However, without an actual sample returned for investigation it's difficult to perform thorough investigation and understand the real failure of this device.Other information from this complaint mentioned the patient was in painful for the second catheter inserted and the patient having a fever night after, which had suggesting there is an infectious, but the origin cause of the infection was not determined from the catheter or others as the patient having multiple devices for treatment and monitoring.In current manufacturing process, the catheters are subjected to 100% water leak test after funnel molding process.Catheter funnel and shaft will be immersed into water with continuous air flow to check for any leak or blockage.Any defects will be segregated before proceeding to next process.After completed assembled, the catheters are then being inflated with air at 1.5 times the inflation volume before being tested for any leakage.The balloons are then subjected to leak test for 20 minutes and upon completion of the test, will be subjected to deflation process.Products that passed all the tests and completed eto sterilization will be shipped out.Catheter leak may happen due to various reason.However, with the absence of the actual sample return for investigation, conclusive failure analysis is unable to perform.Thus, the complaint is not confirmed.

Manufacturer Narrative

(b)(4).The child was born with a left diaphragmatic hernia.At the time of the insertion of the catheter, he was ventilator assisted.On the cardiovascular level there was major mixed pah, predominantly pulmonary, precapillary on the ductal shunt and post capillary on the small left ventricle.There was major edematous syndrome with inflation of the right heart requiring fluid restriction and diuretic therapy with lasix and aldactone since (b)(6) 2019.Enteral feeding was being administered due to under-nourishment.The child needed a cvc due to a left diaphragmatic hernia.On (b)(6) the child was intubated and ventilated and had an extremely severe arterial pulmonary hypertension in addition with a right heart failure and oligo-anuria with edematous syndrome.Febrile peaks caused fear of sepsis.Other remarks: the use of a cvc on (b)(6) was justified by the need for ivc and midazolam ivc morphine sedation to avoid respiratory desynchronization with mechanical ventilation and arterial pulmonary hypertension surges.Infections from cvc leak and tracheal enterobacter cloacae were treated with antibiotics such as vancomycin, meropenem, amiklin, clamoxyl.The period of treatment is reported as (b)(6) 2019 through (b)(6) 2019.The patient needed a urinary catheter for monitoring the diuresis with quantification because of the use of furosemide and oligo-anuria and because of the use of opioid and the risk of acute retention of urine.The origin of the urinary catheter leak was outside the baby according to the nurse.The death report: tuesday (b)(6) 2019, inescapable deterioration of the hemodynamic and respiratory monitoring parameters of the child despite the continuation of the maximum therapies mentioned above.Extubating the child under sedation, with stop amines, in the arms of the parents, in agreement with the parents, in the afternoon.

• Brand Name: BRILLANT 100% SIL FOLEY 1.5ML PED
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 8549784
• MDR Text Key: 143386618
• Report Number: 8040412-2019-00104
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2019

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 Catalogue Number: 170003-000060
• Device Lot Number: 17HE32
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 04/03/2019; 12/09/2019
• Supplement Dates FDA Received: 07/11/2019; 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 5