MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CLEAR ADVANTAGE MALE CONTINENCE SHEATH; MALE EXTERNAL CATHETER

Catalog Number 786225

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

Patient Problem Unspecified Infection (1930)

Event Date 09/08/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 device was not returned.

Event Description

It was reported that the customer used male external catheter for a long time.It was stated that the packaging of the product had recently changed, previously was hard plastic but now the product comes in a soft foam type packaging, and they did not feel they were sterile in this new packaging.Also, two of the male external catheters in the box had holes in, noticed the male external had material inside and nodules on the outside of the catheter which user feels had caused infections.The user extremely concerned about the products not being sterile in the new packaging and pieces of material found in the product.It was noted that the patient regularly experienced infections since the product packaging had changed.It was also stated that the leg bags, has had a few bags which has had the tube that connect to male external catheter back to front.It was unknown what medical intervention was provided for infection.

Event Description

It was reported that the customer used male external catheter for a long time.It was stated that the packaging of the product had recently changed, previously was hard plastic but now the product comes in a soft foam type packaging, and they did not feel they were sterile in this new packaging.Also, two of the male external catheters in the box had holes in, noticed the male external had material inside and nodules on the outside of the catheter which user feels had caused infections.The user extremely concerned about the products not being sterile in the new packaging and pieces of material found in the product.It was noted that the patient regularly experienced infections since the product packaging had changed.It was also stated that the leg bags, has had a few bags which has had the tube that connect to male external catheter back to front.It was unknown what medical intervention was provided for infection.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be "materials not biocompatible".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and states 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 device was not returned.

• Brand Name: CLEAR ADVANTAGE MALE CONTINENCE SHEATH
• 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: 17835169
• MDR Text Key: 324490456
• Report Number: 1018233-2023-07115
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071720
• UDI-Public: (01)00801741071720
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 786225
• Device Lot Number: JUHP9030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• 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
• Patient Outcome(s): Other
• Patient Sex: Male