MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDIA ALL SILICONE AQUAFIL FOLEY CATHETER MALE LENGTH WITH 10ML BALLOON; SILICONE FOLEY CATHETER

Catalog Number 165816

Device Problem Scratched Material (3020)

Patient Problems Calcium Deposits/Calcification (1758); Hemorrhage/Bleeding (1888); Scar Tissue (2060); Tissue Damage (2104); Urinary Retention (2119)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the catheter allegedly, had a hard edge on the end of it.Upon removal of the catheter, the patient allegedly, immediately experienced bleeding upon urination and damage to delicate urethral tissue and compromised urine flow.The torn tissue healed with scar tissue which became a stricture or narrowing of the urethral opening causing a moderate bulbous urethral stricture, that lead to urinary retention which resulted in calcifications in the bladder, a urinary tract infection; requiring antibiotics for treatment, and bladder damage to include bladder stones, which allegedly required bladder surgery and the need for multiple urethral dilations.As a result of the reported ailments, the patient was unable to empty their bladder and allegedly had to alternatively use an intermittent straight catheterization device.

Manufacturer Narrative

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 states the following: "storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).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.The device was not returned.

Event Description

It was reported that the catheter allegedly, had a hard edge on the end of it.Upon removal of the catheter, the patient allegedly, immediately experienced bleeding upon urination and damage to delicate urethral tissue and compromised urine flow.The torn tissue healed with scar tissue which became a stricture or narrowing of the urethral opening causing a moderate bulbous urethral stricture, that lead to urinary retention which resulted in calcifications in the bladder, a urinary tract infection; requiring antibiotics for treatment, and bladder damage to include bladder stones, which allegedly required bladder surgery and the need for multiple urethral dilations.As a result of the reported ailments, the patient was unable to empty their bladder and allegedly had to alternatively use an intermittent straight catheterization device.

• Brand Name: BARDIA ALL SILICONE AQUAFIL FOLEY CATHETER MALE LENGTH WITH 10ML BALLOON
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6249017
• MDR Text Key: 64761483
• Report Number: 1018233-2017-00094
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 165816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2017
• 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): Hospitalization; Required Intervention