MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY NEEDLE, HEPARIN FLUSHING, 1 7/8 IN; HEPARIN FLUSHING NEEDLE

Model Number	45-8002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "we have been using the heparin flushing needle 18 gauge olive tips (manufacturer number: (b)(4)) consistently without issue.However, following our recent purchase of additional units, several doctors have reported that the needles are snapping in half during procedures.This is a significant concern as the previous batch did not present any such problems, and it is impacting clinical operations.".
Additional Manufacturer Narrative
We are in process of trying to get the device returned for evaluation.The investigation is ongoing.Once additional relevant information is identified, it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The device was not returned for evaluation and no pictures were provided of the broken device.The lot information we were given does not match any lot we have produced, so we were also unable to confirm the lot number.We received no additional information despite repeated attempts.The complaint could not be confirmed and no root cause was determined.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: SYMMETRY NEEDLE, HEPARIN FLUSHING, 1 7/8 IN
• Common Device Name: HEPARIN FLUSHING NEEDLE
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: terry hall ; 3034 owen drive; antioch, TN 37013 ; 6166987100
• MDR Report Key: 22588931
• Report Number: 3007208013-2025-00036
• Device Sequence Number: 13010692
• Product Code: GEA
• UDI-Device Identifier: 00887482012918
• UDI-Public: 00887482012918
• Combination Product (Y/N): N
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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
• Operator of Device: Health Professional
• Device Model Number: 45-8002
• Device Lot Number: E220591/30/03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown