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

Device Problems Fluid/Blood Leak (1250); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

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 foley catheter was leaking.Representative tried to explain that there should not be any leaking around the foley.Also suggested the patient to follow up with the provider or nurse who placed the foley, as the device may not be placed correctly.The cause could be the balloon may not have enough inflation or the patient might needs a different sized foley.Hence the patient asked representative regarding addition of water.Representative explained that it depends on the size of the balloon.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.It was unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be mishandling of device by user.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 the foley catheter was leaking.Representative tired to explain that there should not be any leaking around the foley.Also suggested the patient to follow up with the provider or nurse who placed the foley, as the device may not be placed correctly.The cause could be the balloon may not have enough inflation or the patient might needs a different sized foley.Hence the patient asked representative regarding addition of water.Representative explained that it depends on the size of the balloon.Per follow up on 15jul2021, it was reported the customer had the incorrect size catheter and moved to a larger size which stopped the leaking.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: LATEX FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12008887
• MDR Text Key: 256481945
• Report Number: 1018233-2021-03545
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other