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

Model Number	175818
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the foley catheter had fell out.Customer reported that the three different patients had their lubrisil foley catheters fall out despite being secured by statlocks and the catheter balloons being filled.It was stated that two of the patients had new lubrisil catheters fitted, but these also fell out.The customer was unsure what may have caused these issues, but the user works on ward 3, and they have identified that the majority of the staff were positioning the statlock incorrectly and therefore leaving too much slack.It was also stated that they have now provided training on this.As far as i know, no other areas in the hospital were experiencing these issues.
Event or Problem Description
It was reported that the foley catheter had fell out.Customer reported that the three different patients had their lubrisil foley catheters fall out despite being secured by statlocks and the catheter balloons being filled.It was stated that two of the patients had new lubrisil catheters fitted, but these also fell out.The customer was unsure what may have caused these issues, but the user works on ward 3, and they have identified that the majority of the staff were positioning the statlock incorrectly and therefore leaving too much slack.It was also stated that they have now provided training on this.As far as i know, no other areas in the hospital were experiencing these issues.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "imperfection in balloon due to process".The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.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." 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.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Common Device Name: 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: 17276252
• Report Number: 1018233-2023-04936
• Device Sequence Number: 3567498
• Product Code: EZL
• UDI-Device Identifier: 00801741034176
• UDI-Public: (01)00801741034176
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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
• Operator of Device: Health Professional
• Device Model Number: 175818
• Device Catalogue Number: 175818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown