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

Device Problems Inaccurate Flow Rate (1249); Incorrect Measurement (1383)

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

Event Date 02/20/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the foley catheter was used during the operation for urine drainage.It was found that the bladder irrigation lumen of the catheter was narrow, not reaching the standard diameter of the cavity.Then a new catheter was immediately replaced.There were no adverse events.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be wrong product size selected, control panel circuiting problem, speed controller faulty, amplifier card faulty, drying parameters wrongly set, or incorrect material supplied.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to review the labelling due to unknown product code.Although the product family was unknown, the foley catheter ifus were found to be adequate based on past reviews.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.H3 other text: the device was not returned.

Event Description

It was reported that the foley catheter was used during the operation for urine drainage.It was found that the bladder irrigation lumen of the catheter was narrow, not reaching the standard diameter of the cavity.Then a new catheter was immediately replaced.There were no adverse events.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16654908
• MDR Text Key: 312461288
• Report Number: 1018233-2023-02186
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• 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): Other