MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES INJETAK ADJUSTABLE TIP NEEDLE; NEEDLE TIP CATHETER

Model Number DIS199

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/14/2018

Event Type  malfunction  

Event Description

While using a laborie injetak adjustable tip needle, the needle was not coming out of the catheter far enough.

• Brand Name: INJETAK ADJUSTABLE TIP NEEDLE
• Type of Device: NEEDLE TIP CATHETER
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES; williston VT
• MDR Report Key: 7344658
• MDR Text Key: 102833543
• Report Number: MW5075901
• Device Sequence Number: 1
• Product Code: FBK
• 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: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: DIS199
• Device Catalogue Number: DIS199
• Device Lot Number: D168088
• 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: 80 YR