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

Catalog Number 171305-000180

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 12/17/2019

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 during use the balloon deflated and the nurse had to re-inflate on a regularly basis the balloon.The balloon was inflated with sterile water 12 ml.We have that kind of incidents with other sizes.

Event Description

It was reported that during use the balloon deflated and the nurse had to re-inflate on a regularly basis the balloon.The balloon was inflated with sterile water 12ml.We have that kind of incidents with other sizes.

Manufacturer Narrative

(b)(4).Product catalogue mentioned does not contained in the lot provided.Therefore, a dhr review could not be conducted.An actual sample was returned for investigation.Refer to the complaint description, it was likely that the balloon had a leaked.Visual examination was performed on the returned representative catheter and no material degradation or abnormalities observed.The entire components appeared to be in good condition.The sample was inflated with l0ml of air.The balloon inflated normally and after 20 minutes, the sample could stay inflate with no issue and no leak was observed.Then, the sample was deflated using an empty syringe without any problem arise.Leak balloon may happen due to several reasons such as contact with sharp object during use i.E.Contact with clamper, kidney dish/tray , overinflating or contact with contradict lubricants such as oil based antiseptic phenols or their derivatives, grease, petroleum jelly , petroleum spirit, paraffin or other relatives' compounds.Balloon could also leak as a result of balloon had come in contact with bladder or kidney stone during use for patient with bladder or kidney stone history.In our standard operating procedure, the balloons are subjected to 100% visual inspection and any defective raw balloon will be culled out prior sent to the next process.Upon completion of assembly process , the completed assembly catheters were subjected again to 100% balloon inspection and 20 minutes leak test.Catheter with defective balloon will be culled out during this process.Based on the investigation conducted, the returned sample was able to be inflated and deflated without any issue.No other abnormality found and sample able to perform as intended.As such, this complaint is not confirmed.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9496546
• MDR Text Key: 177376957
• Report Number: 8040412-2019-00375
• 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: 12/17/2019

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: 171305-000180
• Device Lot Number: 10KE46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1