MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 NATURAL NON-ADHESIVE MALE EXTERNAL CATHETER

Model Number 38303

Device Problem Material Twisted/Bent (2981)

Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the patient was using male external catheter without adhesive and velcro strap size 32mm.Also, the device kept crimping up when using, which resulted in urine leak and even blood.The patient had to go to the emergence department and the doctor told that the patient did not turn much at all and the crimping was a response to heat and the catheter welded closed.Per follow up response received via phone on 21dec2020, the catheter got twisted to the point where it did not drain and the urine backed up in patient's bladder, which resulted in bleeding and caused blood clots and then prevented the patient from voiding.The customer reportedly ended up in the emergency room as a result, where a 3 way foley catheter was placed purge the bladder and the patient was released.Also, the customer recommended changing the color of the packaging with the velcro band because they were difficult to locate with the current color.

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 "component kinked or damaged from the supplier." 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 was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "description/indication the natural¿ catheter is a non-adhesive, all-silicone male external catheter designed for the management of male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Precautions: do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for periods longer than 24 hours may increase the risk of complications.Applying strap tightly may cause injury to the penis from decreased circulation.Keep strap clean and dry.Directions: to apply catheter wash penis with mild soap and warm water.Dry thoroughly.Trim pubic hair if necessary.Unroll catheter over penis.Gently wrap strap over catheter around penis and secure with hook and loop.Closure.Ensure strap remains over catheter sheath.(to maintain hook and loop.Closure function, keep hook and loop closed when strap is not in use.) important: to avoid injury, do not over tighten strap.Connect to drainage device.To remove catheter remove strap by separating hook and loop closure.Gently roll catheter off the penis." correction:e, h 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.

Event Description

It was reported that the patient using the male external catheter without adhesive and velcro strap size 32 mm.Also, the device kept crimping up when using, which resulted in urine leak and even blood.The patient went to the emergency department and the doctor said that the patient did not turn much at all and the crimping was a response to heat and the catheter was welded closed.Per follow-up response received via phone on 21dec2020, the catheter twisted to the point where it did not drain and the urine backed up in the patient's bladder, which resulted in bleeding and caused the blood clots and then prevented the patient voiding.The customer reportedly ended up in the emergency room as a result, where a 3 way foley catheter was placed to purge the bladder and the patient was released.Also, the customer recommended changing the color of the package with the velcro band because they were difficult to locate with the current color.

• Brand Name: NATURAL NON-ADHESIVE MALE EXTERNAL CATHETER
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11142263
• MDR Text Key: 226011471
• Report Number: 1018233-2020-22415
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071249
• UDI-Public: (01)00801741071249
• 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,other
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 38303
• Device Catalogue Number: 38303
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention