MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE, LUER LOCK, STERILE, 20ML

Model Number	SYR120010
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "black particles" were noted in a medication vial after the syringe drew up its contents.
Additional Manufacturer Narrative
It was reported that "black particles" were noted in a medication vial after the syringe drew up its contents.No serious injury or adverse impact to a patient or a user was originally reported.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.Samples of opened syringes and a used vial were returned for evaluation.The reported problem/issue was confirmed.Additional information received from the reporting facility indicated that a hypodermic-regular bevel needle was used to draw medication.Such a needle is not designed to penetrate medical vials and blunt tip needles should be used instead.The root cause was determined to be use error.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.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: SYRINGE, LUER LOCK, STERILE, 20ML
• 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: 19009703
• Report Number: 1417592-2024-00319
• Device Sequence Number: 7993654
• Product Code: FMF
• UDI-Device Identifier: 40080196310228
• UDI-Public: 40080196310228
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SYR120010
• Device Lot Number: 180430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/01/2024
• 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