MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-SYR W/NDLE,SAFETY,27GX0.5", 1ML

Model Number	SYRS101272FZ
Medical Device Problem Codes	Leak/Splash (1354); Suction Problem (2170); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the needle-syringe connection was inadequate.According to the physician reporter, the needle detached from the syringe when the needle cap was pulled off, the connection became loose resulting in leakage while injecting, and that it was difficult to draw up using the syringe.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.An unused sample was returned for evaluation.Visual inspection revealed no manufacturing defects that would prevent the sample from working as designed.During functional testing, the needle and syringe were connected and simulated administration medication was performed by drawing up fluid.No issues were identified and the needle remained securely attached to the syringe with no leaking observed.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.
Event or Problem Description
It was reported that the needle-syringe connection was inadequate.

• Common Device Name: DBD-SYR W/NDLE,SAFETY,27GX0.5", 1ML
• 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: 18865238
• Report Number: 1417592-2024-00168
• Device Sequence Number: 15513916
• Product Code: FMF
• UDI-Device Identifier: 30888277222483
• UDI-Public: 30888277222483
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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: SYRS101272FZ
• Device Lot Number: 01010004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 03/08/2024
• 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