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

Catalog Number 170605-000160

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2019

Event Type  malfunction  

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 came to ips postoperatively.When the blanket was folded back, the indwelling catheter was in bed, the balloon was emptied.By ips care a new dk was inserted, shortly thereafter, the dk slid out again (blocked balloon was broken).Renewed dk deposit with the same process.The patient has not been diagnosed as suffering from any encrustations or bladder stones.Suspected bladder ca insisted (is not confirmed).Lubricant instilled a gel was used.Catheters placed for max.10 sec.Catheter inserted for transurethral drainage of the bladder by a very experienced user.No patient injury/patient condition is fine.Problem was solved by insertion of a cystofix.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection test.Visual inspection on returned sample observed the balloon was still inflated and no any other abnormalities throughout the catheter.Further investigation was conducted by deflating the balloon when connecting to the syringe and it was observed the balloon was able to deflate smoothly without any difficulties.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.Based on the analysis carried out on the returned sample, the catheter was fully functional upon test conducted.The balloon was able to stay inflated and deflated without any abnormalities observed or difficulties faced.Since there was no product dis-functionality issue observed based on reported failure, therefore this complaint could not be confirmed.

Event Description

It was reported that the patient came to ips postoperatively.When the blanket was folded back, the indwelling catheter was in bed, the balloon was emptied.By ips care a new dk was inserted, shortly thereafter, the dk slid out again (blocked balloon was broken).Renewed dk deposit with the same process.The patient has not been diagnosed as suffering from any encrustations or bladder stones.Suspected bladder ca insisted (is not confirmed).Lubricant instilled a gel was used.Catheters placed for max.10 sec.Catheter inserted for transurethral drainage of the bladder by a very experienced user.No patient injury/patient condition is fine.Problem was solved by insertion of a cystofix.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9341223
• MDR Text Key: 183695101
• Report Number: 8040412-2019-00327
• 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,u
• Type of Report: Initial,Followup
• Report Date: 10/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Catalogue Number: 170605-000160
• Device Lot Number: 19CE10
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1