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 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2016, the distributor reported to rymed that they had received notification that their customer had experienced an issue with the product.Reported that when rn was initially flushing the cap, the cap fell apart.Did not reached the patient.No patient injury; never reached the patient.1 sample was received (b)(6) 2016.It was confirmed that there was 1 incident where the connector separated prior to use.No additional details surrounding the incident are available.(b)(4).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: 15014348
• MDR Text Key: 304714737
• Report Number: 3005951712-2016-00021
• 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
• Source Type: Distributor
• 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

• 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: 04/20/2016
• Initial Date Manufacturer Received: 04/08/2016
• Initial Date FDA Received: 07/14/2022
• 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