MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 WIDEBAND¿ SELF-ADHERING MALE EXTERNAL CATHETER

Model Number 36103

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Pressure Sores (2326)

Event Date 01/12/2023

Event Type  Injury  

Event Description

It was reported that the customer was having issues with the adhesive on the male external catheters.The customer had two boxes of catheters (batch#: jugt1701 and batch#: jugu9119).On 14dec2022, the customer stated that the box of catheters were not working and they kept coming off.The customer stated that they had to change the catheters four times because they kept coming off.So the representative recommended to use the product from the bottom of the box as the top product might be defective on 14dec2022.On 15dec2022, the customer stated that they picked the catheters from the bottom as recommended by representative.However, the customer had to change 2 catheters as they were still coming off and the patient was getting wet.On 18dec2022, the customer stated that the patient was not able to get into their chair because they kept getting wet and had to stay in bed.The customer could not go out because they had to make sure to keep changing the patient's catheter and clean them so that they do not get infections.They could not go out because the catheters kept leaking.Per follow-up information received on 27jan2023, stated that both of the boxes of condoms leaked.The patient ended up with an injury and had an open wound in their butt due to all the wetness getting in from the urine.It was hard to leave the house as the patient was getting wet all the time.They were confined to staying inside during the holidays because of the big leaks.The glue was not sticking well.The customer had a few that did work out of the 2 boxes, but mostly they had to change at least 3 times a day.The customer was not happy with the product due to the amount of time they spent to keep the patient dry, waking up at night to change the patient and also due to the injury that the patient had sustained from the product.Per follow-up information received on 31jan2023, stated that the wound care nurse looked at the wound and was treating it.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "mechanical failure".The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿intended use: the self-adhering male external catheter is used for the drainage of urine.The catheter is applied by the patient or caregiver.Description / indication: the self-adhering male external catheter is designed for the management of adult male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Warning: reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury or illness of the patient.Precaution: do not use if allergic reaction occurs or if patient has known allergies to device components.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Follow directions to remove if experiencing swelling, numbness, discomfort, pain, discoloration, or abnormal appearance.Note: if experiencing problems with use of the device, please consult your healthcare professional for assistance.Directions to apply: verify correct size prior to use.Trim pubic hair if necessary.Wash penis with mild soap and warm water.Dry thoroughly.Wear time may be reduced if skin is not dry or cream/oil is used.Open package at perforation.Remove catheter from plastic insert, if present.Place rolled end over the end of the penis, leaving a small space between the end of the penis and the cone of the catheter.Unroll the catheter over penis.Gently squeeze the catheter to properly seal adhesive to the skin.If possible, avoid leaving a rolled ¿collar¿ around the base of the penis.Important: wear time may be reduced if adhesive is not properly sealed to the skin.Connect the catheter to a drainage system.Make sure to check that connections are secure before use.Directions to remove: ensure drainage bag is empty.Disconnect catheter from the drainage system.Gently roll the catheter forward and off the penis.If necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.Disposal: after removal, dispose by placing the used catheter into a waste container.¿.

Event Description

It was reported that the customer was having issues with the adhesive on the male external catheters.The customer had two boxes of catheters (batch#: jugt1701 and batch#: jugu9119).On (b)(6) 2022, the customer stated that the box of catheters were not working and they kept coming off.The customer stated that they had to change the catheters four times because they kept coming off.So the representative recommended to use the product from the bottom of the box as the top product might be defective on (b)(6) 2022.On (b)(6) 2022, the customer stated that they picked the catheters from the bottom as recommended by representative.However, the customer had to change 2 catheters as they were still coming off and the patient was getting wet.On (b)(6) 2022, the customer stated that the patient was not able to get into their chair because they kept getting wet and had to stay in bed.The customer could not go out because they had to make sure to keep changing the patient's catheter and clean them so that they do not get infections.They could not go out because the catheters kept leaking.Per follow-up information received on 27jan2023, stated that both of the boxes of condoms leaked.The patient ended up with an injury and had an open wound in their butt due to all the wetness getting in from the urine.It was hard to leave the house as the patient was getting wet all the time.They were confined to staying inside during the holidays because of the big leaks.The glue was not sticking well.The customer had a few that did work out of the 2 boxes, but mostly they had to change at least 3 times a day.The customer was not happy with the product due to the amount of time they spent to keep the patient dry, waking up at night to change the patient and also due to the injury that the patient had sustained from the product.Per follow-up information received on 31jan2023, stated that the wound care nurse looked at the wound and was treating it.

Event Description

It was reported that the customer was having issues with the adhesive on the male external catheters.The customer had two boxes of catheters (batch# jugt1701 and batch# jugu9119).On (b)(6) coming off.The customer stated that they had to change the catheters four times because they kept coming off.So the representative recommended to use the product from the bottom of the box as the top product might be defective on (b)(6) 2022.On (b)(6) 2022, the customer stated that they picked the catheters from the bottom as recommended by representative.However, the customer had to change 2 catheters as they were still coming off and the patient was getting wet.On (b)(6) 2022, they customer stated that the patient was not able to get into their chair because they kept getting wet and had to stay in bed.The customer could not go out because they had to make sure to keep changing the patient's catheter and clean them so that they do not get infections.They could not go out because the catheters kept leaking.Per follow-up information received on 27jan2023, stated that both of the boxes of condoms leaked.The patient ended up with an injury and had an open wound in their butt due to all the wetness getting in from the urine.It was hard to leave the house as the patient was getting wet all the time.They were confined to staying inside during the holidays because of the big leaks.The glue was not sticking well.The customer had a few that did work out of the 2 boxes, but mostly they had to change at least 3 times a day.The customer was not happy with the product due to the amount of time they spent to keep the patient dry, waking up at night to change the patient and also due to the injury that the patient had sustained from the product.Per follow-up information received on 31jan2023, stated that the wound care nurse looked at the wound and was treating it.

Manufacturer Narrative

The reported event is inconclusive as the evaluated representative sample meets specifications and original condition of the sample is unknown.Although an exact root cause could not be determined a potential root cause could be mechanical failure.A review of the dhr did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: ¿intended use: the self-adhering male external catheter is used for the drainage of urine.The catheter is applied by the patient or caregiver.Description/indication: the self-adhering male external catheter is designed for the management of adult male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Warning: reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury or illness of the patient.Precaution: do not use if allergic reaction occurs or if patient has known allergies to device components.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Follow directions to remove if experiencing swelling, numbness, discomfort, pain, discoloration, or abnormal appearance.Note: if experiencing problems with use of the device, please consult your healthcare professional for assistance.Directions to apply: verify correct size prior to use.Trim pubic hair if necessary.Wash penis with mild soap and warm water.Dry thoroughly.Wear time may be reduced if skin is not dry or cream/oil is used.Open package at perforation.Remove catheter from plastic insert, if present.Place rolled end over the end of the penis, leaving a small space between the end of the penis and the cone of the catheter.Unroll the catheter over penis.Gently squeeze the catheter to properly seal adhesive to the skin.If possible, avoid leaving a rolled ¿collar¿ around the base of the penis.Important: wear time may be reduced if adhesive is not properly sealed to the skin.Connect the catheter to a drainage system.Make sure to check that connections are secure before use.Directions to remove: ensure drainage bag is empty.Disconnect catheter from the drainage system.Gently roll the catheter forward and off the penis.If necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.Disposal: after removal, dispose by placing the used catheter into a waste container.¿ h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: the actual/suspected device was inspected.

• Brand Name: WIDEBAND¿ SELF-ADHERING MALE EXTERNAL CATHETER
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16365175
• MDR Text Key: 309484134
• Report Number: 1018233-2023-00841
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070990
• UDI-Public: (01)00801741070990
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 36103
• Device Catalogue Number: 36103
• Device Lot Number: JUGU9119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male