MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP; HUBER NEEDLE

Catalog Number LH-0031

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem No Information (3190)

Event Date 06/26/2018

Event Type  malfunction  

Event Description

Safe step huber needle safety did not engage when removing from pt.

• Brand Name: SAFESTEP
• Type of Device: HUBER NEEDLE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; salt lake city UT 84116
• MDR Report Key: 7752573
• MDR Text Key: 116286658
• Report Number: MW5078878
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LH-0031
• 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 Age: 61 YR
• Patient Weight: 91