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

Device Problem Incorrect Measurement (1383)

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

Event Date 02/03/2023

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 8french foley catheters used in a pediatric code, failed when attempting to inflate the balloon during the insertion attempts.When another catheter was removed and inspected, it was noted that there were multiple holes in the catheter itself and the balloon was unable to inflate.Another catheter was inspected that was sent down from the pediatric floor and the same issue was noted with their supply as well.The 10french foley catheters were not noted to have malfunctioned, but could not be used as they were too small for the patient.This issue caused the intubated pediatric patient to not have a foley catheter in place prior to being flown out to another hospital.

Event Description

It was reported that 8french foley catheters used in a pediatric code, failed when attempting to inflate the balloon during the insertion attempts.When another catheter was removed and inspected, it was noted that there were multiple holes in the catheter itself and the balloon was unable to inflate.Another catheter was inspected that was sent down from the pediatric floor and the same issue was noted with their supply as well.The 10french foley catheters were not noted to have malfunctioned, but could not be used as they were too small for the patient.This issue caused the intubated pediatric patient to not have a foley catheter in place prior to being flown out to another hospital.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.H11: section a through f - the information provided by bd represents all 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.

• Brand Name: UNKNOWN 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: 16435751
• MDR Text Key: 310251649
• Report Number: 1018233-2023-01184
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• 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: 03/06/2023
• 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