MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; NEURO RADIOLOGY

Model Number DYNJ67417A

Device Problem Contamination (1120)

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

It was reported that a "black spec" was noted within a syringe component.

Manufacturer Narrative

It was reported that a "black spec" was noted within a syringe component.According to the reporting facility, the foreign particulate was identified prior to patient use.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 photo was provide for review and the two (2) syringes photographed were observed to have black particulate inside of them.No physical sample was returned for evaluation.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.

• Type of Device: NEURO RADIOLOGY
• 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: 18980716
• MDR Text Key: 339209671
• Report Number: 1423395-2024-00207
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 40195327068586
• UDI-Public: 40195327068586
• 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: 03/26/2024

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: DYNJ67417A
• Device Lot Number: 23FMD719
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other