MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PORT ACCESS KIT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	PA-0031YN
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Attempted to flush port; leaking of saline noted just above clave cap during flush, and tubing at this level noted to be cracked/leaking.

• Brand Name: PORT ACCESS KIT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 17583748
• Report Number: 17583748
• Device Sequence Number: 17044226
• Product Code: FPA
• UDI-Device Identifier: 00801741085536
• UDI-Public: (01)00801741085536
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/18/2023
• Report Date (Section F): 05/18/2023

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 Model Number: PA-0031YN
• Device Catalogue Number: PA-0031YN
• Device Lot Number: REGZ1812
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 86 KG
• Date Report Sent to FDA: 05/18/2023