MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LUBRI-SIL FOLEY CATHETERS; UNKNOWN LUBRI-SIL FOLEY CATHETERS

Catalog Number UNKNOWN

Device Problem Partial Blockage (1065)

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

Event Date 03/28/2022

Event Type  malfunction  

Event Description

It was reported that the survey respondent mentioned about bacteriuria, symptomatic urinary tract infection, pain, catheter blockage , leakage and bladder stone(s) when they were asked of complications while using the lubri-sil all -silicone hydrogel coated foley catheter (1758 (12-24)).It was unknown what medical intervention was provided.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿lumen wall thickness undersized".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the lubrisil foley catheter ifus are found to be adequate based on past reviews.The device was not returned.

Event Description

It was reported that the survey respondent mentioned about bacteriuria, symptomatic urinary tract infection, pain, catheter blockage , leakage and bladder stone(s) when they were asked of complications while using the lubri-sil all -silicone hydrogel coated foley catheter (1758 (12-24)).No medical intervention was provided.

• Brand Name: LUBRI-SIL FOLEY CATHETERS
• Type of Device: UNKNOWN LUBRI-SIL FOLEY CATHETERS
• 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: 14187710
• MDR Text Key: 289969173
• Report Number: 1018233-2022-02844
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

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 Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 07/26/2022
• 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
• Patient Sex: Male