MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 UNKNOWN ALL SILICONE CATHETER

Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
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.Udi format updated with available product information per gudid.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 or Problem Description
It was reported that on (b)(6) the customer received one box containing 12 catheters.The customer reported that two units were faulty and exhibited leakage at the time of receipt.No additional information regarding patient use or adverse events was reported.During the initial contact, the facility associates inquired about the possibility of shipping replacement product to the customer.It was communicated during the call that a product investigation must be completed before determining whether replacement product can be provided.This note is included to document the request made during the first contact.
Additional Manufacturer Narrative
Corrections made to tab(s) d and g.The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The reported product number is unknown.The udi number for this product is not available.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 or Problem Description
It was reported that on (b)(6) the customer received one box containing 12 catheters.The customer reported that two units were faulty and exhibited leakage at the time of receipt.No additional information regarding patient use or adverse events was reported.During the initial contact, the facility associates inquired about the possibility of shipping replacement product to the customer.It was communicated during the call that a product investigation must be completed before determining whether replacement product can be provided.This note is included to document the request made during the first contact.

• Brand Name: UNKNOWN ALL SILICONE CATHETER
• Common Device Name: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 24830221
• Report Number: 1018233-2026-02347
• Device Sequence Number: 10306202
• Product Code: EZL
• UDI-Device Identifier: 00801741076077
• UDI-Public: (01)00801741076077
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2026

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
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: 04/10/2026; 05/14/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 04/21/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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