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

Catalog Number 0165SI16

Device Problem Difficult to Remove (1528)

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

Event Date 03/26/2024

Event Type  malfunction  

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 they were demonstrating how to play a surestep latex foley catheter on an anatomical model at a skills fair in the past couple weeks.They attempted to deflate the balloon in the anatomical model using passive deflation and then other methods but was unable to get the balloon to deflate.They needed to use scissors to pop for the foley to remove from the model.They saved this foley, and they would go pick it up to be returned to be evaluated on 27mar2023 at palomar.There were multiple event at this hospital over past 6 months with foley balloon unable to be deflated.Per customer follow up received on 01apr2024, it was reported that the physical sample was given to bd representative, natalie.Initial reporter states there was no patient involvement, catheter but being used on a mannequin.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d,g.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 they were demonstrating how to play a surestep latex foley catheter on an anatomical model at a skills fair in the past couple weeks.They attempted to deflate the balloon in the anatomical model using passive deflation and then other methods but was unable to get the balloon to deflate.They needed to use scissors to pop for the foley to remove from the model.They saved this foley, and they would go pick it up to be returned to be evaluated on 27mar2023 at palomar.There were multiple event at this hospital over past 6 months with foley balloon unable to be deflated.Per customer follow up received on 01apr2024, it was reported that the physical sample was given to bd representative, (b)(6).Initial reporter states there was no patient involvement, catheter but being used on a mannequin.

Event Description

It was reported that they were demonstrating how to play a surestep latex foley catheter on an anatomical model at a skills fair in the past couple weeks.They attempted to deflate the balloon in the anatomical model using passive deflation and then other methods but was unable to get the balloon to deflate.They needed to use scissors to pop for the foley to remove from the model.They saved this foley, and they would go pick it up to be returned to be evaluated on 27mar2023 at palomar.There were multiple event at this hospital over past 6 months with foley balloon unable to be deflated.Per customer follow up received on 01apr2024, it was reported that the physical sample was given to bd representative, natalie.Initial reporter states there was no patient involvement, catheter but being used on a mannequin.

Manufacturer Narrative

The reported event is inconclusive due to poor sample condition.It is unknown whether the device had met relevant specification.A potential root cause for this failure mode could be thin rubberize wall (example: causing collapse/pinched inflation lumen under the 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: "insert foley catheters only for appropriate indications and leave in place only as long as needed.Cdc guidelines for appropriate indications for indwelling urethral catheter use: patient has acute urinary retention or bladder outlet obstruction; need for accurate urine output measurements; use for selected surgical procedures; to assist in healing of open sacral or perineal wounds; patient requires prolonged immobilization; to improve comfort for end of life care.Proper techniques for urinary catheter insertion: perform hand hygiene immediately before and after insertion; insert urinary catheters using aseptic technique and sterile equipment; use the smallest foley catheter possible, consistent with good drainage; document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record.Proper techniques for urinary catheter maintenance: secure the foley catheter.Use the statlock® foley stabilization device if provided; maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions; maintain unobstructed urine flow and keep the catheter and collection tube free from kinking; keep the collection bag below the level of the bladder or hips at all times; empty the collection bag regularly using a separate, clean collection container for each patient.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract." 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® I.C. 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: 19095649
• MDR Text Key: 340810435
• Report Number: 1018233-2024-02026
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016752
• UDI-Public: (01)00801741016752
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040658
• 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
• Report Date: 04/30/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0165SI16
• Device Lot Number: MYGX1267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• 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