MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-SEPTOPLASTY PACK

Model Number DYNJ17645A

Device Problem Infusion or Flow Problem (2964)

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

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that a control syringe component's line of spray "goes all over" instead of being a "controlled line of spray." at the time of the original report, the reporting facility confirmed that the reported problem/issue did not cause or contribute to any injuries.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.A sample was returned for evaluation and visual inspection identified no damage to the component.Functional testing was performed and no major abnormalities were observed with the flow of the component.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a control syringe component's line of spray "goes all over.".

• Type of Device: DBD-SEPTOPLASTY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18865276
• MDR Text Key: 337207637
• Report Number: 1423395-2024-00215
• Device Sequence Number: 1
• Product Code: OGR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ17645A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other