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

Lot Number ASGSFC020

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2023

Event Type  Injury  

Event Description

When deaccessing the patient's port, the safety function of the huber needle malfunctioned.When holding the hub down and pulling up on the needle, it gets stuck and the nurse has to let go of the hub and pull needle out without the safety sheath covering the needle.

• Brand Name: SAFESTEP HUBER NEEDLE SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; salt lake city UT 84116
• MDR Report Key: 16844216
• MDR Text Key: 314364636
• Report Number: MW5117147
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: ASGSFC020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White