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

Model Number 165814

Device Problem Burst Container or Vessel (1074)

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

Event Date 02/07/2022

Event Type  malfunction  

Event Description

It was reported that the foley catheter was inserted at the beginning of the case and during mid case it was noted that the catheter fell out.Customer stated that upon inspection the catheter balloon was found to have a crack in it.The affected lots were lot# ngfv3730, lot# ngfu4400.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "wall thickness too thin".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A review of the device history record did not show any problem or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions are needed.The device was not returned for evaluation.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: "sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not resterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.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 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 (e.G., prior to transport) using a separate, clean collection container for each patient.Routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate.Leave foley catheter in place only as long as needed." corrections: g.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that the foley catheter was inserted at the beginning of the case and during mid case it was noted that the catheter fell out.Customer stated that upon inspection the catheter balloon was found to have a crack in it.The affected lots were lot# ngfv3730, lot# ngfu4400.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE 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: 13653466
• MDR Text Key: 286535324
• Report Number: 1018233-2022-00982
• Device Sequence Number: 1
• Product Code: GBM
• UDI-Device Identifier: 00801741029745
• UDI-Public: (01)00801741029745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K760093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 165814
• Device Catalogue Number: 165814
• Device Lot Number: NGFV3730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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