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

Model Number CPA00026

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/05/2023

Event Type  malfunction  

Event Description

Port deaccessed from patient, placed on bedside table for dressing to be placed to patient.Once picked up to dispose of needle, needle stick occurred to nurse due to needle not fully retracting into device.

• Brand Name: SAFESTEP
• 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: 18639735
• MDR Text Key: 334529755
• Report Number: 18639735
• Device Sequence Number: 1
• Product Code: FPA
• 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: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CPA00026
• Device Catalogue Number: CPA00026
• Device Lot Number: REHP3188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 58 KG