MAUDE Adverse Event Report: OCEANA THERAPEUTICS; NEEDLE, DEFLUX METAL

Model Number 10-35810

Device Problem No Flow (2991)

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

Event Date 11/07/2016

Event Type  malfunction  

Event Description

The medication could not be injected through the metal deflux needle that came with it.We tried to flush normal saline through the needle and it would not flush through either.We opened two of the metal deflux needles and they both were defective.Both of the lot numbers are on this form.There was no injury to the patient.

• Type of Device: NEEDLE, DEFLUX METAL
• Manufacturer (Section D): OCEANA THERAPEUTICS; 2035 lincoln highway, suite 2150; edison NJ 08817
• MDR Report Key: 6088761
• MDR Text Key: 59462984
• Report Number: 6088761
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10-35810
• Device Lot Number: 531002 &511018
• Other Device ID Number: 3.7FR X 3G
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR