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

Catalog Number 175816

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/19/2024

Event Type  malfunction  

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.H3 other text : the device was not returned.

Event Description

It was reported that urine was not being completely collected in the foley catheter.Urine was going in the catheter and around it.Nursing attempted to inflate the catheter to correct, and it did not help.Urine was leaking on the underpad on the patient bed.No visible leakage in the urine meter or the catheter, urine was just going around the catheter.Routine leakage around the foley catheter.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "bad fit with connector".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "1.Wash hands and don clean gloves 2.Explain procedure to patient and open peri-care kit 3.Use the provided packet of wipes to cleanse patient¿s periurethral area 4.Remove gloves and perform hand hygiene with provided alcohol hand sanitizer gel 5.Using proper aseptic technique open csr wrap 6.Don sterile gloves 7.Place underpad beneath patient, plastic/¿shiny¿ side down note: use caution tomaintain aseptic technique 8.Position fenestrated drape on patient 9.Saturate 3 foam swab sticks in povidone iodine 10.Attach the water filled syringe to the inflation port note: it is not necessary to pre-test the foley catheter balloon 11.Remove foley catheter from wrap and lubricate catheter 12.Prepare patient with 3 foam swab sticks saturated in povidone iodine.Use the nondominant hand for the genitalia and the dominant hand for the swabs" 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 urine was not being completely collected in the foley catheter.Urine was going in the catheter and around it.Nursing attempted to inflate the catheter to correct, and it did not help.Urine was leaking on the underpad on the patient bed.No visible leakage in the urine meter or the catheter, urine was just going around the catheter.Routine leakage around the foley catheter.

• Brand Name: BARDEX® LUBRI-SIL® 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18885284
• MDR Text Key: 337631258
• Report Number: 1018233-2024-01256
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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 Catalogue Number: 175816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/14/2024
• 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