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

Model Number 0165L16

Device Problem Dent in Material (2526)

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

Event Date 04/29/2022

Event Type  malfunction  

Event Description

It was reported that the staff was placing a foley catheter on a patient in labor and delivery.Stated that the nurse could not get the balloon to fully inflated and stay inflated.Upon removal, they noted that the balloon was blowing up lop sided and was very difficult to inflated also.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be user related (example: under-inflation during use)/ assembly of the balloon to the shaft/ uneven thickness of balloon.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: "visually inspect the product for any imperfections or surface deterioration prior to use.If the package is opened or if any imperfection or surface deterioration is observed, do not use.Proper techniques for urinary catheter insertion perform hand hygiene immediately before and after insertion.Insert urinary catheters using aseptic techniques and sterile equipments.Use the smallest foley catheter possible, consistent with good drainage.Document the indications of catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record." 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.The device was not returned.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.A potential root cause for this failure mode could be ''under cured sac'' (example: poor shape/ baggy sac-nonconcentric balloon).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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.If the package is opened or if any imperfection or surface deterioration is observed, do not use.Proper techniques for urinary catheter insertion - perform hand hygiene immediately before and after insertion - insert urinary catheters using aseptic techniques and sterile equipments - use the smallest foley catheter possible, consistent with good drainage.- document the indications of catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record.¿ correction: d, g, 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.The actual/suspected device was inspected.

Event Description

It was reported that the staff was placing a foley catheter on a patient in labor and delivery.Stated that the nurse could not get the balloon to fully inflated and stay inflated.Upon removal, they noted that the balloon was blowing up lop sided and was very difficult to inflated also.Per additional information received via sample form on (b)(6) 2022, stated that the catheter was inserted into patient and then attempt was made to inflate balloon.It was very difficult to push the plunger on the syringe and when fluid did move, it was found to be blowing up the tubing by the hub.The catheter was removed upon inspection was found to be inflating at the hub, rather than the balloon.

• Brand Name: BARDEX® LUBRICATH® 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14459683
• MDR Text Key: 292378545
• Report Number: 1018233-2022-03962
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017483
• UDI-Public: (01)00801741017483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0165L16
• Device Catalogue Number: 0165L16
• Device Lot Number: MYFU0122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• 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