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

Catalog Number	0166L28
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while irrigating the pediatric patient¿s 2-way foley catheter tubing the customer was meeting lot of resistance and the patient was crying.It was also appeared that the tube had come out slightly due to the patient pushing it out.Then they re inserted and re taped the tube before continuing.They contacted the clinical instructor for the day and was told there were 2 ports on the tube.One was to inflate the balloon, and the other was for the irrigation.Then they was told that they were attempting to irrigate through was the balloon port, so by mistake they tried to interrogate that tube and thus inflated the balloon instead.It was noted that abdominal x-ray was performed and the patient had some mild bleeding and required no intervention as confirmed by x-ray and surgeon exam.The patient was comfortable and discharged.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 while irrigating the pediatric patient¿s 2-way foley catheter tubing the customer was meeting lot of resistance and the patient was crying.It was also appeared that the tube had come out slightly due to the patient pushing it out.Then they re inserted and re taped the tube before continuing.They contacted the clinical instructor for the day and was told there were 2 ports on the tube.One was to inflate the balloon, and the other was for the irrigation.Then they was told that they were attempting to irrigate through was the balloon port, so by mistake they tried to interrogate that tube and thus inflated the balloon instead.It was noted that abdominal x-ray was performed and the patient had some mild bleeding and required no intervention as confirmed by x-ray and surgeon exam.The patient was comfortable and discharged.
Additional Manufacturer Narrative
The reported event is confirmed - use related as per the reported event because the patient was using the catheter for off label use.The root cause for this failure could be "user violation of standard practice".A dhr review is not required as the event is use related.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." correction: f,h.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: BARDEX® LUBRICATH® 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: 18893259
• Report Number: 1018233-2024-01290
• Device Sequence Number: 7458794
• Product Code: KOD
• UDI-Device Identifier: 00801741017643
• UDI-Public: (01)00801741017643
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0166L28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 03/29/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 24 MO
• Patient Sex: Unknown