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

Catalog Number 170605-000140

Device Problem Deflation Problem (1149)

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

Event Date 09/15/2020

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 the removal of the catheter, the balloon was not fully deflated despite the fact that we made several tries to deflate it.Approximately 2 milliliters remained in the balloon.Consequence: a bleeding appeared during the removal of the catheter, this bleeding stopped after few minutes.There was no hematuria after.

Manufacturer Narrative

Qn# (b)(4).The device lot number was not provided; therefore , a dhr review could not be conducted.There was no actual or representative complaint sample returned for evaluation, thus no physical assessment was conducted.Balloon could not be deflated may be due to several reasons.Due to there was no actual sample returned for this complaint, any further investigation was not possible.Thus, this complaint cannot be confirmed.

Event Description

It was reported that: during the removal of the catheter, the balloon was not fully deflated despite the fact that we made several tries to deflate it.Approximately 2 milliliters remained in the balloon.Consequence: a bleeding appeared during the removal of the catheter, this bleeding stopped after few minutes.There was no hematuria after.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 10599867
• MDR Text Key: 209342888
• Report Number: 8040412-2020-00193
• 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: 09/15/2020

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: 170605-000140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1