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

Catalog Number 1758SI16

Device Problem Material Invagination (1336)

Patient Problem Laceration(s) (1946)

Event Date 10/04/2023

Event Type  Injury  

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 the foley bulb was deflated, and there was resistance during attempt to remove.The bulb was further deflated and resistance persisted.Bulb was inflated and deflated again with saline, and despite use of lubricant it was difficult to remove.Cystourethroscopy and urethroplasty were performed.A thin rim was noted to be present after removal, and superficial laceration was noted along posterior edge of urethral meatus.This region was repaired using 4-0 monocryl using interrupted stitches parallel to the lumen of the urethra.A 70-degree cystoscopic telescope was inserted into the bladder lumen which was filled in a retrograde fashion.The bladder lumen was carefully visualized in its entirety and no signs of masses, lesions, abnormal vascular patterns, or fistulas were noted.No bladder injury was noted.The trigone and both ureteral orifices were identified and found to be normal.Both ureteral orifices were noted to spill dye confirming ureteral patency.The urethra was then visualized upon extraction of the cystoscope and found to be normal with the exception of sutures at inferior meatus.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be due to "incorrect balloon design (balloon wall thickness excessive)".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." 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.H3 other text: the device was not returned.

Event Description

It was reported that the foley bulb was deflated, and there was resistance during attempt to remove.The bulb was further deflated and resistance persisted.Bulb was inflated and deflated again with saline, and despite use of lubricant it was difficult to remove.Cystourethroscopy and urethroplasty were performed.A thin rim was noted to be present after removal, and superficial laceration was noted along posterior edge of urethral meatus.This region was repaired using 4-0 monocryl using interrupted stitches parallel to the lumen of the urethra.A 70-degree cystoscopic telescope was inserted into the bladder lumen which was filled in a retrograde fashion.The bladder lumen was carefully visualized in its entirety and no signs of masses, lesions, abnormal vascular patterns, or fistulas were noted.No bladder injury was noted.The trigone and both ureteral orifices were identified and found to be normal.Both ureteral orifices were noted to spill dye confirming ureteral patency.The urethra was then visualized upon extraction of the cystoscope and found to be normal with the exception of sutures at inferior meatus.

• Brand Name: BARDEX® LUBRI-SIL® I.C. 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17981581
• MDR Text Key: 326243381
• Report Number: 1018233-2023-07621
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1758SI16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 11/14/2023
• 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): Required Intervention