MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD; PORT ACCESS SYSTEM

Model Number AN142010G

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  Injury  

Event Description

Nursing was setting up a sterile field to access a pt port a cath.When nurse opened the 20 gauge, 1 inch needle.It was found to be bent.Nurse unable to use this needle and retrieved a new one to complete procedure.No pt harm.

• Brand Name: BARD
• Type of Device: PORT ACCESS SYSTEM
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC. ; salt lake city UT 84116
• MDR Report Key: 7553107
• MDR Text Key: 109675205
• Report Number: MW5077498
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: AN142010G
• Device Catalogue Number: AN142010G
• Device Lot Number: RECQ2253
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention