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

Model Number 1758SI18

Device Problem Inflation Problem (1310)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2020

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 two of the 18 fr foley catheter have experienced balloon failure.The balloon would not inflate.No medical intervention.

Manufacturer Narrative

The reported event was unconfirmed as the problem could not be reproduced.Visual inspection noted 6 unopened foley trays were received.Visual evaluation noted no obvious defects.All 6 foley catheters were inflated with methylene blue and water and were able to be inflated normally and fills were complete.The balloon rested for 30 minutes without leaks and passively deflated without issue or cuffing, returning 10ml of solution.All catheters measured to be 18fr.The product met specifications.It was determined that the product had no relationship to the event due to the investigation being unconfirmed through sample evaluation.The investigation indicated that the reported issue was unconfirmed, therefore, a device history record review was not required.The instructions for use were found adequate and state the following: "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".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.

Event Description

It was reported that two of the 18 fr foley catheter have experienced balloon failure.The balloon would not inflate.No medical intervention was reported.

• Brand Name: BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10032168
• MDR Text Key: 190480994
• Report Number: 1018233-2020-03085
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741025235
• UDI-Public: (01)00801741025235
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1758SI18
• Device Catalogue Number: 1758SI18
• Device Lot Number: NGDU2774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1