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	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint was reported by a customer from usa.A leakage issue was reported.It was reported that no human harm occurred, and no medical intervention was required as a result of this event.
Additional Manufacturer Narrative
Investigation type: eitan medical investigated history records of the lot used by the customer.Investigation findings: 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 usa.A leakage issue was reported.It was reported that no human harm occurred, and no medical intervention was required as a result of this event.
Additional Manufacturer Narrative
Investigation type: the initial report submitted on 24-jul-2025, presents the lot history review.Since then, the same lot as the one used by the customer has not been received for investigation despite multiple follow-up attempts made by eitan medical.Investigation findings: the set has not been received for investigation despite multiple follow-up attempts made by eitan medical.Conclusion: eitan medical has conducted multiple attempts to receive the set itself, for investigation.However, it was not provided by the customer.If the set is provided by the customer, an investigation will be conducted, and the investigation's findings will be presented in a follow up report.

• 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: 22584931
• Report Number: 3010293992-2025-00048
• Device Sequence Number: 14593776
• Product Code: FPA
• UDI-Device Identifier: 17290109152223
• UDI-Public: (01)17290109152223(10)1392300424(17)260730
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/14/2025

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: 07/24/2025
• Supplement Report FDA Received Date: 09/14/2025
• 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): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown