MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SYRINGE, 10ML SALINE IN 10ML

Catalog Number	EMZ111240
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that on 6/5/2024, "foreign material, brown in color, x2 on iv syringe plunger.Packaging unopened.10cc ns syringe has what appears to be mold on the proximal end of plunger.The device was not used on a patient.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.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 or Problem Description
Foreign material on plunger.

• Common Device Name: SYRINGE, 10ML SALINE IN 10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; 1933 heck ave; neptune NJ
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19667645
• Report Number: 2027791-2024-00075
• Device Sequence Number: 15208028
• Product Code: NGT
• UDI-Device Identifier: 00363807000032
• UDI-Public: 00363807000032
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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 Catalogue Number: EMZ111240
• Device Lot Number: 24DJA084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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