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

Model Number 38301

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Urinary Tract Infection (2120)

Event Date 04/12/2022

Event Type  Injury  

Event Description

It was reported that the strap that held the male external catheter on did not last for a full 10 days.Patient only got 7 days out of them.Representative stated that if the patient used them for the full 10 days the patient might get urinary tract infection (uti).Per follow up information response received via phone on (b)(6) 2022, reported that the patient had a latex and adhesive allergy.Also reported that the patient had 3 severe uti¿s (urinary tract infection) in the last few months and was treated by doctor with antibiotics.Representative also stated that needed more straps each month for the male external catheter.It was unknown if the device contributed to the urinary tract infection at this time.

Manufacturer Narrative

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

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".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is 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 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) unroll catheter over penis.4) 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 overtighten strap.5) connect to drainage device.To remove catheter 1) remove strap by separating hook and loop closure.2) gently roll catheter off the penis".H11: section a through f - the information provided by bard 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 bard.

Event Description

It was reported that the strap that held the male external catheter on did not last for a full 10 days.Patient only got 7 days out of them.Representative stated that if the patient used them for the full 10 days the patient might get urinary tract infection (uti).Per follow up information response received via phone on 12apr2022, reported that the patient had a latex and adhesive allergy.Also reported that the patient had 3 severe uti¿s (urinary tract infection) in the last few months and was treated by doctor with antibiotics.Representative also stated that needed more straps each month for the male external catheter.It was unknown if the device contributed to the urinary tract infection at this time.Per follow up information received on 18may2022, customer reported that the patient had latex allergy.Also had 2 uti¿s (urinary tract infection) and did seek medical attention and was prescribed antibiotics.Also stated that there should be more straps per month for the male external catheter.It was unknown if the device contributed to the urinary tract infection at this time.Per additional information received via email on 03jun2022, customer stated that the catheters they ordered did not come with enough straps.Also stated that there are 3 straps per box of 30 catheters and that they needed at least 6 straps per box, and preferably one strap per catheter.Also stated that was unsanitary to try to reuse three straps and then the patient developed a urinary tract infection (uti) because of this, and health was affected.Customer requested about for two 30-day supply boxes of catheters size 29mm, not 25mm, so that they could use straps but was sent boxes of catheters with no straps.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14309609
• MDR Text Key: 290932008
• Report Number: 1018233-2022-03383
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071225
• UDI-Public: (01)00801741071225
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 38301
• Device Catalogue Number: 38301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male