MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL; CATHETER, RETENTION TYPE, BALLOON

Catalog Number 170605-000120

Device Problem Deflation Problem (1149)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported event: after advancing a rusch brillant 12 ch it was difficult to inflate the cuff with 3 ml nacl probably due to the incorrect position in the urethra, the attempt to deflate the catheter was not possible, so that the catheter was advanced into the bladder after consultation with the urological colleagues, but it was also not possible to deflate the catheter.It was burst with 40 ml in a controlled manner; the catheter was completely removed.The device was placed postoperatively in a ventilated patient in an intensive care setting.No medical intervention was performed; all parts of the balloon were removed completely.The nacl was used to burst the balloon after aspiration was not possible and an attempt was made to cut off the tube of the balloon.The patient was discharged on (b)(6) 2023 in good condition.

Manufacturer Narrative

Qn#(b)(4).No alleged sample was returned for investigation.Hence, investigation shall be conducted based on document review.According to the complaint description, the catheter was described to be non-deflation.According to the product description, the balloon capacity recommended is 10ml.According to the ifu d60514 in case of non-deflating balloons, cut the catheter shaft at the bifurcation of perforate the balloon according to established procedures.Ifu states, "in case of non-deflating balloons cut the catheter shaft at the bifurcation or perforate the balloon according to established procedures.If the balloon ruptures all fragments must be removed from the bladder." non deflation could also happen due to over inflation of the balloon where the excessive aspiration can collapse inflation lumen and asymmetrical condition of the balloon due to overinflation which may result in occlusion of the inflation lumen eye during deflation process.However, since no actual or representative sample returned, the asymmetry ratio could not be measured where the acceptable limit for balloon asymmetry is based on 1:3 per internal requirement of qas-a001: quality assurance inspection criteria for all silicone foleys & special products.In current standard operating procedure as per spm-a51-003, 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 (spm-a52-004).Catheter with defective balloon will be culled out.According to the description of the complaint, there catheter is not fully deflated.There are several potential root causes that may cause the non-deflation.However, without the presence of the physical sample, the root cause could not be identified.Therefore, this complaint could not be confirmed.

Event Description

Reported event: after advancing a rusch brillant 12 ch it was difficult to inflate the cuff with 3 ml nacl probably due to the incorrect position in the urethra, the attempt to deflate the catheter was not possible, so that the catheter was advanced into the bladder after consultation with the urological colleagues, but it was also not possible to deflate the catheter.It was burst with 40 ml in a controlled manner; the catheter was completely removed.The device was placed postoperatively in a ventilated patient in an intensive care setting.No medical intervention was performed; all parts of the balloon were removed completely.The nacl was used to burst the balloon after aspiration was not possible and an attempt was made to cut off the tube of the balloon.The patient was discharged on 16 jan 2023 in good condition.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• 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: 16264970
• MDR Text Key: 308972319
• Report Number: 8040412-2023-00036
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 170605-000120
• Device Lot Number: 20GE30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NONE REPORTED; NONE REPORTED