MAUDE Adverse Event Report: EITAN MEDICAL LTD. AVOSET MICROBORE SET WITH BACKCHECK VALVE; ADMINISTRATION SET

Catalog Number	12222-000-0001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation type: eitan medical inspected the provided pictures and history records of the lot used by the customer.Investigation findings: the complaint was confirmed based on the photo provided by the customer.However, no design or manufacturing discrepancies that could have caused or contributed to a complaint of this nature were identified.Conclusion: the investigation is ongoing and the investigation findings will be detailed in a follow-up report.
Event or Problem Description
This complaint was reported by a customer from the us.A leakage issue was reported.It was reported that no human harm occurred and no medical intervention was required as a result of the event.
Additional Manufacturer Narrative
Investigation type: eitan medical inspected photos provided by the customer.Investigation findings: the complaint was confirmed based on photos provided by the customer.However, no discrepancies that may have caused or contributed to a complaint of this nature were identified.All quality assurance tests performed during the set manufacturing passed successfully.Conclusion: visual inspection of the photo indicates the event was most likely a result of misuse.
Event or Problem Description
This complaint was reported by a customer from the us.A leakage issue was reported.It was reported that no human harm occurred and no medical intervention was required as a result of the event.

• Brand Name: AVOSET MICROBORE SET WITH BACKCHECK VALVE
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): EITAN MEDICAL LTD.; yad harutzim st. 29; netanya, 42505 29; IS 4250529
• Manufacturer (Section G): EITAN MEDICAL LTD.; yad harutzim st. 29; netanya, 42505 29; IS 4250529
• Manufacturer Contact: guy mlechkowich ; yad harutzim st. 29; netanya, 42505-29 ; IS 4250529
• MDR Report Key: 22357940
• Report Number: 3010293992-2025-00046
• Device Sequence Number: 18163259
• Product Code: FPA
• UDI-Device Identifier: 17290109152223
• UDI-Public: (01)17290109152223(10)1392300424(17)260730
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2025

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: Lay User/Patient
• Device Expiration Date: 07/30/2026
• Device Catalogue Number: 12222-000-0001
• Device Lot Number: 1392.3004.24
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown