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

Model Number	SYRS101272FZ
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the syringe draws in an "abundance of air" when attempting to draw up "more than" 0.5ml into the syringe.According to the reporting facility, they felt as though "the plunger is too small for the syringe itself." 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.Eight (8) samples in new condition were returned for evaluation.Functional testing confirmed the reported problem/issue as an excessive amount of air was observed to be visible inside the syringe barrel while drawing fluids.A greater volume of fluid was drawn into tested samples and the root cause was determined to be a defective syringe plunger that did not allow the desired volume of fluids to be drawn in.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 syringe draws in an "abundance of air.".

• 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: 19055756
• Report Number: 1417592-2024-00227
• Device Sequence Number: 7020277
• Product Code: FMF
• UDI-Device Identifier: 30888277222483
• UDI-Public: 30888277222483
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/05/2024

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: 14112120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/05/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown