MAUDE Adverse Event Report: EITAN MEDICAL LTD. AV0001-01- AVOSET MICROBORE SET WITH BACKCHECK VALVE; ASMINISTRATION 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	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation type: eitan medical investigated history records of the lot mentioned 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: no issues were identified based on the data provided by the customer thus far.Eitan medical has requested the device for investigation, as well as clarifying information - none were provided to date.If the device will be provided by the customer, farther investigation will be conducted, and the investigation's findings will be presented in a follow up report.
Event or Problem Description
This complaint was reported by a customer from the usa.A leakage issue was reported.No human harm or medical intervention was reported.

• Brand Name: AV0001-01- AVOSET MICROBORE SET WITH BACKCHECK VALVE
• Common Device Name: ASMINISTRATION 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: 25091269
• Report Number: 3010293992-2026-00037
• Device Sequence Number: 9777697
• Product Code: FPA
• UDI-Device Identifier: 17290109152223
• UDI-Public: (01)17290109152223(10)1392080514(17)260808
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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: 08/08/2026
• Device Catalogue Number: 12222-000-0001
• Device Lot Number: 1392.0805.14
• 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: 05/06/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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