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

Model Number 33302

Device Problems Leak/Splash (1354); Nonstandard Device (1420)

Patient Problems Erythema (1840); Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the male external catheter leaked towards the base of the penis and it was observed that there was red spots at the head of the penis.After 7 to 8 hours of use the patient experienced leak and placed the leg bag below the knee.It was also reported that the adhesive was hard to remove.

Event Description

It was reported that the male external catheter leaked towards the base of the penis and it was observed that there was red spots at the head of the penis.After 7 to 8 hours of use the patient experienced leak and placed the leg bag below the knee.It was also reported that the adhesive was hard to remove.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿operator error.¿ it was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.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: "description/indication: the self-adhering male external catheter is designed for the management of male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Precaution: do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Directions: to apply: 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) unroll self-adhering catheter over penis.4) gently squeeze the catheter to properly seal adhesive to the skin.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.5) connect to drainage device.Directions: to remove: gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive." h11:section a through f - the information provided by bd represents all of 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: ULTRAFLEX SELF-ADHERING MALE EXTERNAL CATHETER
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10245224
• MDR Text Key: 198502958
• Report Number: 1018233-2020-04377
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070754
• UDI-Public: (01)00801741070754
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 33302
• Device Catalogue Number: 33302
• Device Lot Number: JUEP1168
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1