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

Catalog Number 170605-000180

Device Problem Deflation Problem (1149)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 06/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the device had been pre-tested prior to insertion and no issues were observed.When the catheter's position had to be readjusted the nurse could not withdraw the injected 10cc from the balloon with the syringe.The urologist nurse was unable to pierce the balloon using a guidewire through the lumen.Percutaneous puncture of the balloon using a thinner needle and removal of the device.Clinical consequences: during removal of device, slight blood spots in urine (urethrorrhagia) but at the end of the procedure the urine was clear again.Additional information: the patient presented a moderate urethrorrhagia at the end of the gesture, during removal, then the urine became clear again after the new catheter was inserted.There were no further negative consequences.The balloon was stuck in the bulbar urethra.The catheter was inserted on (b)(6) 2020 and the removal was done on the night of (b)(6).The catheter size was ch 18, the lot number is unknown.

Manufacturer Narrative

(b)(4).The device lot number was not provided; therefore , a dhr review could not be conducted.Part of the catheter was returned for investigation.Based on the complaint description, it was reported that when the catheter's position had to be readjusted, the nurse could not withdraw the injected 10cc from the balloon with the syringe which refer to non-deflation.However , returned sample with balloon already burst , therefore it is difficult to conduct further investigation to identify the actual root cause of this failure.Non-deflation could be due to several reasons such as improper fixation of syringe to the valve, faulty valve and blockage of inflation lumen.In a standard practice, an empty syringe without plunger is also recommended to be used to drain off the fluid by gravity and avoid creation of vacuum effect and ease deflation process.Besides that , based on the ifu, it was advice to cut the shaft near the entry site as to allow the liquid to flow out of the balloon if the valve fails to deflate the balloon.Non-deflation could also happen due to the asymmetrical condition of the balloon resulted in occlusion of the inflation lumen eye during deflation process.However, due to burst balloon condition of the returned sample, further investigation could not be conducted to determine the balloon symmetry.In our current standard operating procedure as per spm-asl-003, the products are subjected to 100% visual inspection and any defective raw balloon will be discarded before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection, 20 minutes leak test and 100% deflation process (spm-a52-004).Catheter with defective balloon will be culled out du ring this process.Non-deflation balloon may due to several reasons.However, the returned sample had burst, hence further investigation could not be conducted to identify the actual root cause of this failure.Therefore, this complaint could not be confirmed.

Event Description

It was reported that the device had been pre-tested prior to insertion and no issues were observed.When the catheter's position had to be readjusted the nurse could not withdraw the injected 10cc from the balloon with the syringe.The urologist nurse was unable to pierce the balloon using a guidewire through the lumen.Percutaneous puncture of the balloon using a thinner needle and removal of the device.Clinical consequences: during removal of device, slight blood spots in urine (urethrorrhagia) but at the end of the procedure the urine was clear again.Additional information: the patient presented a moderate urethrorrhagia at the end of the gesture, during removal, then the urine became clear again after the new catheter was inserted.There were no further negative consequences.The balloon was stuck in the bulbar urethra.The catheter was inserted on (b)(6) 2020 and the removal was done on the night on (b)(6).The catheter size was ch 18, the lot number is unknown.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 10179180
• MDR Text Key: 197125352
• Report Number: 8040412-2020-00137
• 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: 06/15/2020

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 Catalogue Number: 170605-000180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention