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

Model Number 119116

Device Problem Inadequate Instructions for Healthcare Professional (1319)

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

Event Date 02/22/2023

Event Type  malfunction  

Event Description

It was reported that in the packaging of 119116 catheter, it was mentioned as silicone elastomer foley catheter.When the user looked at the photo sample, the user thought it was a 100 percent silicone foley catheter.The user asked to confirm which one it was silicone elastomer or 100 percent silicone and it was confirmed that 119116 was a bardex all-silicone temperature-sensing 400-series foley catheter.The user asked about fixing this label on the cover of 119116 as the shaft stated it was a 100% silicone elastomer.The user was not sure how some ous labels differ from us.They found it odd that it stated latex-free and silicone-elastomer and thought it could had different meanings in different countries.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found that there was no allegation against product.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 in the packaging of 119116 catheter, it was mentioned as silicone elastomer foley catheter.When the user looked at the photo sample, the user thought it was a 100 percent silicone foley catheter.The user asked to confirm which one it was silicone elastomer or 100 percent silicone and it was confirmed that 119116 was a bardex all-silicone temperature-sensing 400-series foley catheter.The user asked about fixing this label on the cover of 119116 as the shaft stated it was a 100% silicone elastomer.The user was not sure how some ous labels differ from us.They found it odd that it stated latex-free and silicone-elastomer and thought it could had different meanings in different countries.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING 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: 16548204
• MDR Text Key: 311384929
• Report Number: 1018233-2023-01766
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046032
• UDI-Public: (01)00801741046032
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

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
• Device Operator: Health Professional
• Device Model Number: 119116
• Device Catalogue Number: 119116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/13/2023
• 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): Other