MAUDE Adverse Event Report: C.R. BARD, INC. SAFESTEP HUBER NEEDLE STEP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number LH-0029

Device Problems Material Twisted/Bent (2981); No Flow (2991)

Patient Problem No Code Available (3191)

Event Date 12/12/2018

Event Type  malfunction  

Event Description

Occurred at a hospital infusion center.The patient brought a huber needle provided by home health services.Rn removed the huber needle from the packaging and prepped it per protocol.The needle appeared to have no visible issues and was functioning normally at the time.The rn inserted the needle into the port and checked for blood return.When the needle was inserted, the patient said it felt slightly different from normal, but could not describe how.Rn could not get blood return or flush to go through.There was no pain.The patient turned head and moved their shoulder, but there was still no blood return or flush.The rn removed the needle to find that it was bent at the base roughly 70 degrees from its normal position.The safety feature could not be utilized and the needle was disposed of in sharps container.

• Brand Name: SAFESTEP HUBER NEEDLE STEP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 8175401
• MDR Text Key: 130983630
• Report Number: MW5082211
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066160
• UDI-Public: (01)00801741066160
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/13/2018

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 Expiration Date: 06/28/2021
• Device Model Number: LH-0029
• Device Catalogue Number: LH-0029
• Device Lot Number: ASCUS0262
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 47