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

Catalog Number 170605-000120

Device Problems Fluid/Blood Leak (1250); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

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 an insertion of the urinary catheter, 2 urinary catheters were found: the first catheter was bent at the tip, this was noticed before the catheter was inserted.The second catheter on the balloon was defective.The urinary catheter could be inserted but not blocked.Therefore it was removed again immediately and a leak was noticed on the balloon.The 3rd catheter could then be properly placed.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed and product released met specification.No sample was returned for investigation; therefore, no physical investigation could be conducted.Non-inflation issue could be due to several reasons.However, without any returned samples, any non-inflation issue could not be identified.Therefore, this complaint could not be confirmed.

Event Description

It was reported that during an insertion of the urinary catheter, 2 urinary catheters were found: the first catheter was bent at the tip, this was noticed before the catheter was inserted.The second catheter on the balloon was defective.The urinary catheter could be inserted but not blocked.Therefore it was removed again immediately and a leak was noticed on the balloon.The 3rd catheter could then be properly placed.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 10580291
• MDR Text Key: 208770296
• Report Number: 8040412-2020-00188
• 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: 09/04/2020

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: 170605-000120
• Device Lot Number: 19LG34
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1