MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE, LUER LOCK, STERILE, 10ML

Model Number	SYR110010Z
Medical Device Problem Codes	Suction Problem (2170); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the syringe is "not airtight" and that needle detachment occurred.
Additional Manufacturer Narrative
It was reported that the syringe is "not airtight" resulting in no suction when the syringe plunger is pulled back.Additionally, the reporting facility indicated that a needle detached from the syringe and remained within a patient's arm.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, further medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.The reporting facility provided 17bx of unused syringes for evaluation, however, no samples of the needles used by the reporting facility were provided.Visual inspection and functional testing was performed using 10 randomly selected samples from the returned 17bx of product.Visual inspection revealed no defects or any manufacturing issues preventing the samples from working as intended.Functional testing was performed by attaching a blunt tip needle from stock and drawing fluids from a training vial.No issues were experienced and the fluids were drawn without any lack of suction.Then, the fluids were taken out of the syringes by pushing down the plungers.There were no indications of fluids being left inside the syringes after they were completely flushed.The blunt tip needles were then removed and hypodermic needles from stock were attached to the samples.No luer lock issues were identified and the hypodermic needles securely attached as intended.While the hypodermic needles were attached, they were inserted into an infusion set to ensure the needles were properly attached.There was no indication of needle detachment from any of the syringes tested while inserting the needles into the infusion set.The samples worked as intended.No reported problem/issue was unable to be reproduced or confirmed and a roto 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.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: SYRINGE, LUER LOCK, STERILE, 10ML
• 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: 18865273
• Report Number: 1417592-2024-00162
• Device Sequence Number: 12835846
• Product Code: FMF
• UDI-Device Identifier: 30080196310191
• UDI-Public: 30080196310191
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 03/06/2024

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: SYR110010Z
• Device Lot Number: 180621
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 03/08/2024
• 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