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

Catalog Number 165816

Device Problem Deflation Problem (1149)

Patient Problem Pain (1994)

Event Date 08/21/2023

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.

Event Description

It was reported that the blocked bladder catheter was identified by the nurse as there was no urine in the bag.The nurse wanted to change the foley catheter, but deflated the balloon and was unable to remove the catheter, which seemed to be stuck over the last 2 centimetres.They called the doctor on duty, who had to sedate the patient in order to pull on the catheter forcefully to remove it.The clinical consequences of the event was that the patient had to be sedated for the procedure, pain for the patient and increased risk of infection following removal and reinsertion of the catheter.Per follow-up information received from ibc on 19oct2023, stated that the patient was discharged from the hospital and was doing better.The patient had to be sedated in order to be de-weighted and then re-weighted, as they were suffering from severe pain.There was no notion of urinary infection following the incident, but the patient was already under antibiotic therapy (claforan and flagyl) during their hospitalization (systemic inflammatory syndrome in a context of pancreatitis with episodes of desaturation).

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "incorrect balloon design (balloon wall thickness excessive)".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "sterile: unless package is opened or damaged.Warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Visually inspect the product for any imperfections or surface deterioration prior to use.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." 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 the blocked bladder catheter was identified by the nurse as there was no urine in the bag.The nurse wanted to change the foley catheter, but deflated the balloon and was unable to remove the catheter, which seemed to be stuck over the last 2 centimetres.They called the doctor on duty, who had to sedate the patient in order to pull on the catheter forcefully to remove it.The clinical consequences of the event was that the patient had to be sedated for the procedure, pain for the patient and increased risk of infection following removal and reinsertion of the catheter.Per follow-up information received from ibc on 19oct2023, stated that the patient was discharged from the hospital and was doing better.The patient had to be sedated in order to be de-weighted and then re-weighted, as they were suffering from severe pain.There was no notion of urinary infection following the incident, but the patient was already under antibiotic therapy (claforan and flagyl) during their hospitalization (systemic inflammatory syndrome in a context of pancreatitis with episodes of desaturation).

• 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: 18055473
• MDR Text Key: 327162382
• Report Number: 1018233-2023-07789
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 165816
• Device Lot Number: NGGX1308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• 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