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

Model Number	0103L24
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a foley catheter with 30 cc balloon inserted due to straight catheter unsuccessful.On (b)(6) 2022, the patient was pulling at foley and causing trauma and developed sang discharge in foley.When attempted to remove foley, it was unable to remove due to bulb not deflating.Confirmed on ultrasound that bulb was full with fluid.Attempted client repositioning and multiple attempts to withdraw fluid.Surgical consult was recommended to have an ultrasound guided procedure completed.On (b)(6) 2022, the patient was left to facility 2 for surgical consult.Bulb was deflated and new foley inserted.Removed when back in facility.Incident was thought to have occurred due to faulty equipment and was able to remove about 2.5 ml or less of fluid, unable to remove more.Bulb was not tested/inflated prior to insertion.This was not done due to recent changes to best practice for foley catheter insertion.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the patient had a foley catheter with 30 cc balloon inserted due to straight catheter unsuccessful.On (b)(6) 2022, the patient was pulling at foley and causing trauma and developed sang discharge in foley.When attempted to remove foley, it was unable to remove due to bulb not deflating.Confirmed on ultrasound that bulb was full with fluid.Attempted client repositioning and multiple attempts to withdraw fluid.Surgical consult was recommended to have an ultrasound guided procedure completed.On (b)(6) 2022, the patient was left to facility 2 for surgical consult.Bulb was deflated and new foley inserted.Removed when back in facility.Incident was thought to have occurred due to faulty equipment and was able to remove about 2.5 ml or less of fluid, unable to remove more.Bulb was not tested/inflated prior to insertion.This was not done due to recent changes to best practice for foley catheter insertion.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.The potential root cause for this failure could be "lumen collapses under the pressure of the balloon, pinched lumen;".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.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." 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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• 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: 15626905
• Report Number: 1018233-2022-07956
• Device Sequence Number: 6184742
• Product Code: KOD
• UDI-Device Identifier: 00801741018220
• UDI-Public: (01)00801741018220
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K922431
• 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): 02/21/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0103L24
• Device Catalogue Number: 0103L24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 02/27/2023
• 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: Required Intervention
• Patient Sex: Unknown