MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER; UNKNOWN FOLEY CATHETER

Catalog Number UNKNOWN

Device Problem Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2020

Event Type  malfunction  

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 leak around the catheter might caused by catheter blockage or bladder spasms.Blockage could possibly be from pushing the catheter up too far into the bladder, which could have caused the drainage eyes to become blocked by bladder lining.Spasms could occur when the foley tip touched inside of the bladder making a rippling effect and allowing urine to leak around the catheter when this happened.Some of these potential causes seemed unlikely due to the age of the patient population but cannot be ruled out as potential issues.Per troubleshooting stated that the patient must be aware of using the foley in an off-label manner by not properly inflating the balloon per bard/bd inflation recommendations.

Manufacturer Narrative

The reported event was confirmed as a use related.The product used for urological care.The root cause for this failure mode could be due to low or high latex viscosity or short latex dwell time or latex dip speed out too slow.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore bd was unable to determine the associated labeling to review.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 in an off label manner the foley balloon was not properly inflated as per the bard inflation recommendations.The balloon inflation allowed the tip of the foley to sit inside the bladder away from the bladder walls and when properly inflated with the prescribed sterile water amount caused the tip of the catheter to sit symmetrically in the center of the balloon.It might also keep the foley inside the bladder.A foley balloon is meant to ensure the catheter remains in the bladder.If not properly inflated it might result in leakage around the catheter and also causes the blockage or infection or catheter encrustation and loss of elasticity of the female urethra.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: UNKNOWN FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10984369
• MDR Text Key: 220702797
• Report Number: 1018233-2020-21544
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other