MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. GOLD LATEX FOLEY, CYLINDRICAL,PAEDIATRIC

Catalog Number 180003-000080

Device Problems Deflation Problem (1149); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer reported that patients condition were both diagnosed with acute renal failure (due to hypovolemic shock and the other one septic shock).The medical staff would want to monitor the urine output strictly which led to the decision to insert the catheter.Before catheter insertion, urine was passing with very minimal unquantified amount.Then upon inserting the catheter, there was no urine passage to the bag, or any leakage noted.Catheter remained inserted for 4-6 hours in the patient without any output.As soon the catheter was removed, both patients immediately passed urine.We decided to not insert the catheter anymore on both case and used alternative methods (diaper weighing and placement of clean gloves for the male patient).Both incidents had the same issue not able to pass urine since the catheter was inserted then upon trying to remove it the port failed to deflate the balloon.Precipitation in the tube and obstruction, which prevents passing the fluids through it.The extraction/removal of fluid in the balloon fails in the port.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed 100% insertion.There was no actual or representative complaint sample returned for evaluation, thus no physical assessment was conducted.Non-drainage could be occurred due to several reasons.However, in the absence of returned sample and limited information available on this complaint, further investigation could not be conducted and therefore complaint is not confirmed.

Event Description

Customer reported that patients condition were both diagnosed with acute renal failure (due to hypovolemic shock and the other one septic shock).The medical staff would want to monitor the urine output strictly which led to the decision to insert the catheter.Before catheter insertion, urine was passing with very minimal unquantified amount.Then upon inserting the catheter, there was no urine passage to the bag, or any leakage noted.Catheter remained inserted for 4-6 hours in the patient without any output.As soon the catheter was removed, both patients immediately passed urine.We decided to not insert the catheter anymore on both case and used alternative methods (diaper weighing and placement of clean gloves for the male patient).Both incidents had the same issue not able to pass urine since the catheter was inserted then upon trying to remove it the port failed to deflate the balloon.Precipitation in the tube and obstruction, which prevents passing the fluids through it.The extraction/removal of fluid in the balloon fails in the port.

• Brand Name: GOLD LATEX FOLEY, CYLINDRICAL,PAEDIATRIC
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9855808
• MDR Text Key: 192185083
• Report Number: 8040412-2020-00095
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

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 Expiration Date: 01/31/2020
• Device Catalogue Number: 180003-000080
• Device Lot Number: 15B04
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 04/22/2020
• Supplement Dates FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention