MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATH LAB-CENTURA HEALTH

Model Number	DYNJCEN03A
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a "floating substance" was noted within a syringe component when it was filled with lidocaine.
Additional Manufacturer Narrative
It was reported that a "floating substance" was noted within a syringe component when it was filled with lidocaine.At the time of the original report, the reporting facility indicated that they were "not sure where it came from" and "could be the lido vial, initial syringe used to draw up the med, the cup on the back-table, or the syringe used to draw it up from the back-table that is used for injection/administration." 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.No photo or physical sample was provided for evaluation 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.

• Common Device Name: CATH LAB-CENTURA HEALTH
• 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: 18921564
• Report Number: 1423395-2024-00149
• Device Sequence Number: 12662123
• Product Code: OES
• UDI-Device Identifier: 40888277847805
• UDI-Public: 40888277847805
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2024

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: DYNJCEN03A
• Device Lot Number: 20DBC218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown