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

Model Number DYNJ45121C

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the red ear ulcer syringe component was found to turn the saline solution red.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.Visual inspection identified no color fading or damage.The sample was submerged in sterile water for 30min and no color fading or change in sterile water color was observed.The sample was then wrapped in a microkill wipe to simulate a more aggressive solution contact and left for 5min with no color fading observed.The reported problem/issue was unable to be confirmed and a root cause was unable to be determined.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 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 the red ear ulcer syringe component was found to turn the saline solution red.

• Type of Device: DBD-NEURO 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: 18865225
• MDR Text Key: 337202940
• Report Number: 1423395-2024-00176
• Device Sequence Number: 1
• Product Code: OJG
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ45121C
• Device Lot Number: 19DDC998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 03/08/2024
• 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