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

Model Number LH-0031

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2017

Event Type  malfunction  

Event Description

The rn was attempting to untap the pt's ivad port after completion of treatment.The easy-slide mechanism on the needle did not slide back, so rn needed to pull hard to remove the needle from the port.The needle came out from the center of the easy slide mechanism and did not stop as usual; it came complete apart.

• Brand Name: SAFESTEP HUBER NEEDLE SET
• Type of Device: SAFESTEP HUBER NEEDLE SET
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; salt lake city UT 84116
• MDR Report Key: 6590278
• MDR Text Key: 76030091
• Report Number: MW5070016
• Device Sequence Number: 1
• Product Code: FPA
• 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: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2019
• Device Model Number: LH-0031
• Device Lot Number: ASAYS0028
• Was Device Available for Evaluation?: No
• 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: 70 YR