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

Model Number 1758SI16

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 04/21/2022

Event Type  malfunction  

Event Description

It was reported that the foley catheter was placed intraoperatively.During postoperative recovery stated that it was difficult to remove the catheter.Catheter was advanced into catheter with additional emptying of urine.Stated that the balloon port was then cut and the catheter was removed with gentle force.After removal a thin ridge was noted on the tip of the catheter.

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 the foley catheter was placed intraoperatively.During postoperative recovery stated that it was difficult to remove the catheter.Catheter was advanced into catheter with additional emptying of urine.Stated that the balloon port was then cut and the catheter was removed with gentle force.After removal a thin ridge was noted on the tip of the catheter.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be " error of inspector".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "bard® ez-lok® sampling port (indicated by the blue stem in the port) accepts luer lock (fig.1a) or slip tip syringes (fig.1b).1.Occlude drainage tubing a minimum of 3 inches below the sampling port by kinking the tubing until urine is visible under the access site.2.Swab surface of bard® ez-lok® sampling port with antiseptic wipe.(fig.2) 3.Using aseptic technique, position the syringe in the center of the sampling port.Press the syringe firmly and twist gently to access the sampling port.(fig.3) 4.Slowly aspirate urine sample into syringe and remove syringe from sample port.5.Unkink tubing if necessary and transfer urine specimen into specimen cup or follow hospital protocol.Discard syringe according to hospital protocol.6.Follow established hospital protocol for specimen labeling and transport to lab.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 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.H3 other text : the device was not returned.

• 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 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: 14408085
• MDR Text Key: 291966925
• Report Number: 1018233-2022-03791
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741025228
• UDI-Public: (01)00801741025228
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1758SI16
• Device Catalogue Number: 1758SI16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/16/2022
• Supplement Dates Manufacturer Received: 07/30/2022
• Supplement Dates FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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