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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER Back to Search Results
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.
 
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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 Key17981581
MDR Text Key326243381
Report Number1018233-2023-07621
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741025228
UDI-Public(01)00801741025228
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040504
Number of Events Reported1
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 Number1758SI16
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/04/2023
Initial Date FDA Received10/20/2023
Supplement Dates Manufacturer Received11/08/2023
Supplement Dates FDA Received11/14/2023
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 Number1
Patient Outcome(s) Required Intervention;
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