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

Model Number IPN050265

Device Problem Sharp Edges (4013)

Patient Problems Pain (1994); Discomfort (2330); Genital Bleeding (4507)

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "when the catheter was removed, this led to very heavy bleeding with a clot in the patient's urethra, which necessitated the use of bladder washes".As a result, a new catheter was inserted.There was "no visible bleeding at the level of the bladder, user thinks there might be a problem of friction between the catheter and the urethra".The patient status is reported as "fine".

Manufacturer Narrative

Qn# (b)(4).There was no sample returned for investigation.However, in review of a previous complaint retained sample product catalogue 171305-000180 and lot number kme21j0029 no sharp edges, kink, flashing or any damage was observed.In review of the ifu for the product there are contraindications and potential complications during usage of this catheter included.Verification of the reported defect cannot be conducted without the returned product.Device history record (dhr) review was conducted for the lot number kme23c1254 with no relevant findings.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "when the catheter was removed, this led to very heavy bleeding with a clot in the patient's urethra, which necessitated the use of bladder washes".As a result, a new catheter was inserted.There was "no visible bleeding at the level of the bladder, user thinks there might be a problem of friction between the catheter and the urethra".The patient status is reported as "fine".

• Brand Name: BRILLANT 2-W SILICONE FOLEY, TIEMANN
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17551938
• MDR Text Key: 321425913
• Report Number: 8040412-2023-00324
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K972184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

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 Model Number: IPN050265
• Device Catalogue Number: 171305-000180
• Device Lot Number: KME23C1254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.