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

Model Number 165816

Device Problems Fluid/Blood Leak (1250); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the nurse was re-inflated the foley catheter balloon for some reason.It was stated that they were not sure if they thought it had a leak, but the balloon was fully inflated and had remained that way since the issue occurred.And stated that they never had anyone re-inflated a balloon before.Per follow up via phone on (b)(6) 2022, the customer reported that this was the fourth complaint that they have received concerning an issue with a foley catheter.Customer analyzed and felt that issues are primarily due to user error.Customer reported that based on analysis, nurses are leaving syringes in the catheter balloons and not filling them properly.Per additional information received on 26aug2022, it was reported that the representative noted drainage to chux pad under the patient and damp area at meatus.It was also stated that foley leaking around catheter.Per follow up via phone on (b)(6) 2022, it was reported that the nurses were not totally filling the balloon part of the foley.

Event Description

It was reported that the nurse was re-inflated the foley catheter balloon for some reason.It was stated that they were not sure if they thought it had a leak, but the balloon was fully inflated and had remained that way since the issue occurred.And stated that they never had anyone re-inflated a balloon before.Per follow up via phone on 16aug2022, the customer reported that this was the fourth complaint that they have received concerning an issue with a foley catheter.Customer analyzed and felt that issues are primarily due to user error.Customer reported that based on analysis, nurses are leaving syringes in the catheter balloons and not filling them properly.Per additional information received on 26aug2022, it was reported that the representative noted drainage to chux pad under the patient and damp area at meatus.It was also stated that foley leaking around catheter.Per follow up via phone on 01nov2022, it was reported that the nurses were not totally filling the balloon part of the foley.

Manufacturer Narrative

As per investigation findings, the reported event was concluded as use-related.Hence, this mdr is not reportable.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.

Manufacturer Narrative

The reported event was confirmed use related.One sample exhibited the reported failure.The product was used for patient treatment or diagnosis.The product¿s misuse caused the reported failure.The product had not caused the reported failure.The root cause of this failure is failure to follow instructions.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "[directions for use] 1.Method of use (1) cleanse the area around the external urethral meatus with the packaged cotton balls immersed in the antiseptics.(2) lubricate the catheter shaft with the lubricant jelly.(3) carefully insert the catheter into the urethral meatus.After the balloon advanced in the bladder, attach the needleless syringe, and gently infuse the specified volume of sterile water to inflate the balloon.(4) pull the catheter slightly to seat the balloon at the level of the bladder neck.(5) to deflate and remove the balloon, attach a needleless syringe to let sterile water in the balloon come out spontaneously through balloon deflation without aspiration.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered." 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 actual/suspected device was inspected.

Event Description

It was reported that the nurse was re-inflated the foley catheter balloon for some reason.It was stated that they were not sure if they thought it had a leak, but the balloon was fully inflated and had remained that way since the issue occurred.And stated that they never had anyone re-inflated a balloon before.Per follow up via phone on 16aug2022, the customer reported that this was the fourth complaint that they have received concerning an issue with a foley catheter.Customer analyzed and felt that issues are primarily due to user error.Customer reported that based on analysis, nurses are leaving syringes in the catheter balloons and not filling them properly.Per additional information received on 26aug2022, it was reported that the representative noted drainage to chux pad under the patient and damp area at meatus.It was also stated that foley leaking around catheter.Per follow up via phone on 01nov2022, it was reported that the nurses were not totally filling the balloon part of the foley.

Event Description

It was reported that the nurse was re-inflated the foley catheter balloon for some reason.It was stated that they were not sure if they thought it had a leak, but the balloon was fully inflated and had remained that way since the issue occurred.And stated that they never had anyone re-inflated a balloon before.Per follow up via phone on 16aug2022, the customer reported that this was the fourth complaint that they have received concerning an issue with a foley catheter.Customer analyzed and felt that issues are primarily due to user error.Customer reported that based on analysis, nurses are leaving syringes in the catheter balloons and not filling them properly.Per additional information received on 26aug2022, it was reported that the representative noted drainage to chux pad under the patient and damp area at meatus.It was also stated that foley leaking around catheter.Per follow up via phone on 01nov2022, it was reported that the nurses were not totally filling the balloon part of the foley.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.No root cause could be found because the reported event was unconfirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event was unconfirmed a labeling review was not required.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 actual/suspected device was inspected.

• 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: 15813853
• MDR Text Key: 307696999
• Report Number: 1018233-2022-08795
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Device Lot Number: NGGS1287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 02/06/2023; 03/15/2023; 03/27/2023
• Supplement Dates FDA Received: 02/08/2023; 03/15/2023; 03/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2022
• 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): Other