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

Model Number IPN050135

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem Pain (1994)

Event Date 11/16/2019

Event Type  Injury  

Manufacturer Narrative

Qn# (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 placed on post-natal catheter 16.11.In the evening.When the catheter was removed after just under 24 hours, the balloon did not begin to empty at all.Consultation was also made with the urology department, who was instructed to cut the catheter, in which case the balloon should be emptied.However, the balloon did not empty, so the catheter could not be removed.Left catheter in place overnight.Clinical consequences: mom was hurt by the situation when urine leaked through hose bandages etc.The next morning 18.11.Again , trying to empty the balloon in every container.In the end, it was decided to remove the catheter in the operating room under an anesthesia.

Manufacturer Narrative

(b)(6).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.There was no complaint device returned for investigation.Therefore, no physical assessment could be conducted.Balloon could not be deflated may due to various reasons.However, in the absence of returned sample and limited information available on this complaint, further investigation could not be conducted and therefore this complaint is not confirmed.

Event Description

It was reported that the patient placed on post-natal catheter 16.11.In the evening.When the catheter was removed after just under 24 hours, the balloon did not begin to empty at all.Consultation was also made with the urology department, who was instructed to cut the catheter, in which case the balloon should be emptied.However, the balloon did not empty, so the catheter could not be removed.Left catheter in place overnight.Clinical consequences: mom was hurt by the situation when urine leaked through hose bandages etc.The next morning 18.11.Again , trying to empty the balloon in every container.In the end, it was decided to remove the catheter in the operating room under an anesthesia.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9395987
• MDR Text Key: 168644887
• Report Number: 8040412-2019-00358
• 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: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Model Number: IPN050135
• Device Catalogue Number: 170605-000120
• Device Lot Number: 19EE18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention