MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH GUARDIVA AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: section a through f: the information provided by bd represents all of 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.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the customer that a leaking catheter was found, with a hole located at the base near the catheter's hub, requiring the clinician to replace the line.No adverse event or serious injury noted.It was reported this occurred with two devices.This report addresses both devices.
Additional Manufacturer Narrative
H11: the initial complaint was submitted stating that 2 occurrences were being addressed, upon further review the records have been separated and the second occurrence is now being addressed on medwatch report 3006260740-2024-06733.
Event or Problem Description
It was reported by the customer that a leaking catheter was found, with a hole located at the base near the catheter's hub, requiring the clinician to replace the line.No adverse event or serious injury noted.

• Brand Name: FULL KIT 20G X 10 CM WITH GUARDIVA AND PROBE COVER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20501474
• Report Number: 3006260740-2024-06110
• Device Sequence Number: 18247663
• Product Code: FOZ
• UDI-Device Identifier: 00801741140587
• UDI-Public: (01)00801741140587(11)240510(17)250531(10)REJQ0659
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: F120108PT
• Device Lot Number: REJQ0659
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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