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

Model Number 153204

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

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

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that there was an issue with sure step foley tray.Additional information required.Per additional information received via mail on 31aug2020, the balloon was deflated and the foley was removed.When the foley came out there was still about 3ml of saline in the balloon that would could not be removed.

Event Description

It was reported that there was an issue with sure step foley tray.Per additional information received via mail on 31aug2020, the balloon was deflated and the foley was removed.When the foley came out there was still about 3ml of saline in the balloon that would could not be removed.

Manufacturer Narrative

The reported event was unconfirmed.Visual inspection noted one two-way silicone foley catheter was received with the syringe.Visual evaluation noted no obvious defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and balloon concentricity was observed to be 50:50.This meets specification as concentricity should not exceed 70:30.The balloon rested for 30 minutes without leaks and passively deflated without issue or cuffing, returning 10ml of solution.The balloon deflated in 45.6 seconds.The balloon was dissected to measure the distance from the middle of the inflation notch to the bottom of shaft.This measured to be 0.9710" which was found to be within specification (0.97" +/- 0.30").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." 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.

• 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 GA 30014
• MDR Report Key: 10555745
• MDR Text Key: 208349736
• Report Number: 1018233-2020-06061
• Device Sequence Number: 1
• Product Code: GBM
• UDI-Device Identifier: 00801741033117
• UDI-Public: (01)00801741033117
• Combination Product (y/n): N
• PMA/PMN Number: K760093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 153204
• Device Catalogue Number: 165814
• Device Lot Number: NGDR4195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Date Manufacturer Received: 12/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1