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

Model Number LH-0031

Device Problem Retraction Problem (1536)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2023

Event Type  malfunction  

Event Description

Reporter de-accessed patient's port which was accessed with a huber needle set.Safety mechanism faulty and needle did not retract back completely.

• 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: 16435151
• MDR Text Key: 310177579
• Report Number: 16435151
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066207
• UDI-Public: (01)00801741066207
• 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: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LH-0031
• Device Catalogue Number: LH-0031
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1