MAUDE Adverse Event Report: BARD SAFESTEP HUBER NEEDLE

Catalog Number LH0033

Device Problems Fluid/Blood Leak (1250); Split (2537)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Discomfort (2330)

Event Date 06/30/2015

Event Type  Injury  

Event Description

We have been having issues with bard port needles, product number lh-0033.Tubing that is already attached to the port needle has been splitting open at the very end (distal to the needle) causing blood to back up and leak out of the patient, also causing us to have to de-access the needle and put a new one in, sometimes emergently, which inflicts unnecessary pain on our pediatric patients, upsets parents/patients, and puts them at huge risk of infection.Diagnosis or reason for use: use for medication administration.

• Brand Name: SAFESTEP HUBER NEEDLE
• Type of Device: SAFESTEP HUBER NEEDLE
• Manufacturer (Section D): BARD
• MDR Report Key: 4993102
• MDR Text Key: 25256390
• Report Number: MW5055278
• Device Sequence Number: 1
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LH0033
• Other Device ID Number: LH-0033
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention