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

Model Number 0632010

Device Problems Product Quality Problem (1506); Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 09/01/2018

Event Type  malfunction  

Event Description

Staff reported a concern about the quality of the huber needle we are now using (the one we were using is no longer available).Staff report having to stick patients multiple times to access the port.

• 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: 9075177
• MDR Text Key: 158863103
• Report Number: 9075177
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047541
• UDI-Public: (01)00801741047541
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0632010
• Device Catalogue Number: 0632010
• Device Lot Number: ASCNS0129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1