MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL; CATHETER, RETENTION TYPE, BALLOON

Model Number IPN050353

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Skin Tears (2516)

Event Date 08/09/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.

Event Description

Involved male patients in a nursing home.Using permanent catheterization.It's been few days that nurses noticed for several male patients some small cuts on the top of the penis.It's not linked to the balloon.It's like an irritation.The small cuts lead to small bleeding, the issue is that it is not healing for the moment because it's a permanent catheterization.It could be an issue with the positioning of the catheters but we cannot exclude it is an issue with devices.It happened with 2 references (170605-xxxx and 174030-xxxx), sizes are unknown and lot# are unknown.Catheters are still in situ on patients at the time of logging.It will be asked to nurses to keep them when removed.Additional information: the cuts are on the head of the penis.Bleeding occurred for some patient's and sometimes blood seen in urine after device replacement.The patient's wear full diapers with a net to hold tubing and urine bag and bed bag holder.No medical intervention performed and no treatment with antibiotics.The cuts with bleeding have not stopped.

Manufacturer Narrative

Qn#: (b)(4).Report 8040412-2022-00241 is being retracted because the device is not sold in the us.

Manufacturer Narrative

(b)(4).Report initial report is being reinstated.The customer has provided an update with a correction of the catalog number.The updated catalog number shows that the device is sold in the us.

Manufacturer Narrative

(b)(4).The device lot number was not provided; therefore , a dhr review could not be conducted.An actual sample attached with urine bag was returned for investigation.It was reported that elderly male patient was on permanent catheterization and had experienced small bleeding due to a small cut and was likely it is an irritation during catheterization period.Visual examination on the returned sample observed that the catheter and urine bag had turned to blackish color and heavy encrustation observed throughout the sample.Besides that, no other abnormalities or sharp edge detected on returned sample.According to the complaint description, it is believed that the patients are pulling catheters regularly as this kind of issues happened regularly with patients with long term catheterization.Also, it was stated that the catheter was initially not maintained or secured properly and according to an article, pressure ulcers: an unusual complication of indwelling urethral catheter, stated pressure ulcer could occur due to unrelieved pressure on between the soft tissues and hard surface where continual pressure from any source can result in pressure ulcer.Improper securement of the catheter was also observed as one of the causes for pressure ulcers, bedsores and perineal dermatitis due to patient's incontinence.Improper positioning on the catheter may also cause the catheter to migrate from its proper position and place unnecessary tension on the other tissue surface.Thus, proper cleansing procedures and securement methods can decrease the risk for erosive injury and urinary tract infections.Review on manufacturing, there is no change of material or processes that might affect the hardness, flexibility and durability of silicone catheter.The catheter are subject to 100% inspection for its functionality prior to product packing and shipment.According to the ifu for the balloon catheters, there is potential complications such as catheter associated urinary tract infections, urgency and tenesmus, irritations of urethral mucosa and blockage of the catheter due to encrustation.Incorrectly positioned catheter can cause urethral damage id the balloon is inflated within urethra.Due to possible diffusion, it is recommended to check the volume of the balloons inflated with sterile water at least once per week.It is recommended as well to visually inspect the catheter for any mechanical damage before use.In summary, based on the complaint reported, such pressure ulcers phenomenon likely could occur due to continues pressure from any source and improper securement of the catheter.Chances of having pressure ulcers also is generally higher for elderly patient due to their cognitive impairment and limited dexterity nature over extended period.Literature had suggested the importance of medical staff to be aware the need to remove or reposition the device and others as discuss above.Thus, this complaint is not confirmed.

Manufacturer Narrative

Qn#(b)(4).The device lot number was not provided; therefore, a dhr review could not be conducted.An actual sample with urine bag was returned for investigation.It was reported that elderly male patient was on permanent catheterization and had experienced small bleeding due to a small cut and was likely it is an irritation during catheterization period.Visual examination on the returned sample observed that the catheter and urine bag had turned to blackish color and heavy encrustation observed throughout the sample.Besides that, no other abnormalities or rough surface detected on returned sample.According to the complaint description, it is believed that the patients are pulling catheters regularly as this kind of issues happened regularly with patients with long term catheterization regardless any brand or supplier.Also, it was stated that the catheter was initially not maintained or secured properly.Furthermore, based on sap, it was understood that initially the patient was prescribed with product catalog 170605-000180 but in real situation the patient was catheterized with product catalog 174030-000180 due to the nurses using the catheter which was in stock (174030-000180), instead of actual device prescribed.From the user report, the customer also had reported that the cut of the penis resulted from prolonged use (for several years) of a full-time catheterization where the cut appeared almost a year and worsen month by month.According to an article, pressure ulcers: an unusual complication of indwelling urethral catheter, stated pressure ulcer could occur due to unrelieved pressure on between the soft tissues and hard surface where continual pressure from any source can result in pressure ulcer.Improper securement of the catheter was also observed as one of the causes for pressure ulcers, bedsores and perineal dermatitis due to patient's incontinence.Improper positioning on the catheter may also cause the catheter to migrate from its proper position and place unnecessary tension on the other tissue surface.Thus, proper cleansing procedures and securement methods can decrease the risk for erosive injury and urinary tract infections.Review on manufacturing, there is no change of material or processes that might affect the hardness, flexibility and durability of silicone catheter.The catheter are subject to 100% inspection for its functionality prior to product packing and shipment.According to the ifu for the balloon catheters, there is potential complications such as catheter associated urinary tract infections, urgency and tenesmus, irritations of urethral mucosa and blockage of the catheter due to encrustation.Incorrectly positioned catheter can cause urethral damage if the balloon is inflated within urethra.Due to possible diffusion, it is recommended to check the volume of the balloons inflated with sterile water at least once per week.It is recommended as well to visually inspect the catheter for any mechanical damage before use.In summary, based on the complaint reported, such pressure ulcers phenomenon likely could occur due to continuous pressure from any source and improper securement of the catheter.Chances of having pressure ulcers also is generally higher for elderly patient due to their cognitive impairment and limited dexterity nature over extended period.Literature had suggested the importance of medical staff to be aware the need to remove or reposition the device and others as discussed above.Thus, this complaint is not confirmed.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15243530
• MDR Text Key: 304984522
• Report Number: 8040412-2022-00241
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IPN050353
• Device Catalogue Number: 174030-000180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 08/09/2022; 08/09/2022; 09/30/2022; 11/01/2022
• Supplement Dates FDA Received: 08/29/2022; 08/30/2022; 10/01/2022; 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Sex: Male