MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® PEDIATRIC FOLEY CATHETER

Model Number	0165PL08
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be due to ¿lumen collapses under the pressure of the balloon, pinched lumen; kinked lumen.".It was unknown whether the device had met specifications.The provided lot number was invalid therefore dhr review can¿t be completed.The instructions for use were found adequate and states the following: sterile: unless package has been opened or damaged.Warning: do not use ointments or lubricants having a petroleum base.They will damage latex and may burst balloon.Do not aspirate urine through the drainage funnel wall.Single use only.Do not resterile.For urological use only.Valve type: use luer slip syringe.Do not use needle.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.
Event or Problem Description
It was reported that 8 french 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 10 french 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.

• Brand Name: BARDEX® LUBRICATH® PEDIATRIC FOLEY CATHETER
• Common Device Name: 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: 16435463
• Report Number: 1018233-2023-01176
• Device Sequence Number: 3126931
• Product Code: EZC
• UDI-Device Identifier: 00801741017667
• UDI-Public: (01)00801741017667
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0165PL08
• Device Catalogue Number: 0165PL08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown