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

Model Number 0681910

Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312); No Fail-Safe Mechanism (2990)

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

Event Date 05/11/2023

Event Type  malfunction  

Event Description

Bard port needle exposed in packaging.Needle missing protective cover when package opened.No one punctured.

• Brand Name: PORT ACCESS NEEDLE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 17001585
• MDR Text Key: 315926160
• Report Number: 17001585
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047985
• UDI-Public: (01)00801741047985(17)251230(10)ASGZFC145
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/12/2023

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: 0681910
• Device Catalogue Number: 0681910
• Device Lot Number: ASGZFC145
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1