MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, TIEMANN

Catalog Number 171305-000140

Device Problem Leak/Splash (1354)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 03/10/2022

Event Type  malfunction  

Event Description

We had 2 types of cases of leaks with the urinary catheters.Leak at the level of the balloon.Balloon inflated with 13ml and with the syringe the nurse only retrieved 7 ml.Leakage of urine despite a balloon properly inflated.We had to re-catheterized the patients.The patients are elderly and we cannot explain the recurrence of leaks on several patients (man and woman) in recent weeks with catheters from different sizes.Additional information: leaks appeared after 4-5 hours of use.Catheters self-expelled.Patients got irritation of the external urethral orifice; no other medical intervention necessary.

Manufacturer Narrative

(b)(4).One representative sample returned for investigation.Based on the complaint statement, "we had 2 types of cases of leaks with the urinary catheters.1.Leak at the level of the balloon.Balloon inflated with 13ml and with the syringe the nurse only retrieved 7ml.Leakage of urine despite a balloon properly inflated.Attempt to inflate the balloon was easy and balloon was able to be inflated to its required shape and size.The inflated balloon was monitored for more than 30 minutes and the balloons able to remain in inflated condition.Attempt to deflate the balloon did not show any sign of resistance and balloon able to return to its original state.Leak on balloon may happen due to various reasons such as contact with sharp object during use i.E.Contact with clamper, kidney dish/tray.Balloon could also split as a result of balloon had come in contact with bladder or kidney stone during use for patient with bladder or kidney stone history.Based on literature, salty sediment could also possibly lead to balloon tear.(robinson j (2003): deflation of a foley catheter balloon, nursing standard which stated that encrustation stick on the catheter surface and patient urethra resulting into bleeding, scarring or trauma.In our current standard operating procedure, the products are subjected to 100% visual inspection and any defective raw balloon will be culled out before sent to the next process.Upon completion of assembly process the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test.Catheter with defective balloon will be culled out during this process as well.In conclusion, in manufacturing all catheter is 100% inflation and deflation tested and such failure in manufacturing could be detected.Therefore, this complaint could not be confirmed.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, TIEMANN
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15265420
• MDR Text Key: 303147186
• Report Number: 8040412-2022-00248
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2022

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: 171305-000140
• Device Lot Number: KME21E0860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1