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

Model Number 165814

Device Problem Deflation Problem (1149)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/03/2023

Event Type  Injury  

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 Description

It was reported that when the lpn went to remove 10cc of normal saline to deflate the balloon at 1300h, it was able to only aspirate back 3cc of normal saline.The nurse tried multiple times but kept facing resistance.When they tried to pull the catheter out in case the balloon was deflated, the balloon did not come out.Then they tried to cut the catheter which would automatically allow the normal saline to come out, the urine continued to flow out of the catheter but the balloon did not deflate.Troubleshooting included trying to deflate the balloon by inserting a needle into the lumen that goes to the balloon but could not aspirate back any fluid after multiple attempts with different sized needles.Ultrasound was performed to assess the patient's bladder where the balloon appeared to still be inflated.A urologist will have to see the patient later that week to use a needle and ultrasound to puncture the balloon.The catheter was clamped in the meantime and the end of the remaining 14f catheter was inserted into a 22f 3 way catheter which is connected to a foley bag until the patient consults the urologist.

Event Description

It was reported that when the lpn went to remove 10cc of normal saline to deflate the balloon at 1300h, it was able to only aspirate back 3cc of normal saline.The nurse tried multiple times but kept facing resistance.When they tried to pull the catheter out in case the balloon was deflated, the balloon did not come out.Then they tried to cut the catheter which would automatically allow the normal saline to come out, the urine continued to flow out of the catheter but the balloon did not deflate.Troubleshooting included trying to deflate the balloon by inserting a needle into the lumen that goes to the balloon but could not aspirate back any fluid after multiple attempts with different sized needles.Ultrasound was performed to assess the patient's bladder where the balloon appeared to still be inflated.A urologist will have to see the patient later that week to use a needle and ultrasound to puncture the balloon.The catheter was clamped in the meantime and the end of the remaining 14f catheter was inserted into a 22f 3 way catheter which is connected to a foley bag until the patient consults the urologist.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be due to "valve damaged, poor molding,".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.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.Visually inspect the product for any imperfections or surface deterioration prior to use." 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.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: 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: 17009739
• MDR Text Key: 316007766
• Report Number: 1018233-2023-03792
• Device Sequence Number: 1
• Product Code: GBM
• UDI-Device Identifier: 00801741029745
• UDI-Public: (01)00801741029745
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K760093
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 165814
• Device Catalogue Number: 165814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2023
• 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): Required Intervention