MAUDE Adverse Event Report: RYMED TECHNOLOGIES, LLC INVISION-PLUS; NEEDLELESS IV CONNECTOR

Catalog Number 415303

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2016

Event Type  malfunction  

Manufacturer Narrative

This report is a post inspection retrospective review.2016 incident.

Event Description

On 05/09/2016, the distributor reported to rymed that they had received notification that their customer had experienced an issue with the product.It was reported that the valve broke apart before use.No patient injury; never reached the patient.1 sample was received 05/11/2016.It was confirmed that there was 1 incident where the connector separated prior to use.No additional details surrounding the incident are available.Reported as product code 415303, lot unknown.This report is a post inspection retrospective review.2016 incident.

• Brand Name: INVISION-PLUS
• Type of Device: NEEDLELESS IV CONNECTOR
• Manufacturer (Section D): RYMED TECHNOLOGIES, LLC; 6000 w. william cannon drive; bldg b, suite 300; austin TX 78749
• Manufacturer Contact: anna mccutchen ; 6000 w. william cannon drive; bldg b, suite 300; austin, TX 78749 ; 5123017334
• MDR Report Key: 15017710
• MDR Text Key: 302860646
• Report Number: 3005951712-2016-00026
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 415303
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1