MAUDE Adverse Event Report: EITAN MEDICAL LTD. AV0002-01- AVOSET MEDICATION RESERVOIR 100 ML; ADMINISTRATION SET

Catalog Number	12222-000-0002
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint was reported by a customer from usa.A leakage issue was reported.No human harm or medical intervention was reported.
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: eitan medical requested unused cartridges of the same lot (1815.2806.24) for investigation.Once provided, further investigation will be conducted, and the investigation findings will be submitted in the follow up report.
Event or Problem Description
This complaint was reported by a customer from usa.A leakage issue was reported.No human harm or medical intervention was reported.
Additional Manufacturer Narrative
Investigation type: eitan medical investigated the reservoir and the set from the same type and lot as the one used in the event.Investigation findings: the complaint was not confirmed.Both the reservoir and the set from the same type and lot as the one used in the event were visually inspected and tested.No leakage or any other irregularities that could have caused or contributed to the event were observed.Conclusion: as no failures that could have caused or contributed to the event were observed, it is possible that the leakage occurred due to misuse by the user.

• Brand Name: AV0002-01- AVOSET MEDICATION RESERVOIR 100 ML
• 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: 24312977
• Report Number: 3010293992-2026-00008
• Device Sequence Number: 17352898
• Product Code: FPA
• UDI-Device Identifier: 17290109152568
• UDI-Public: (01)17290109152568(10)1815280624(17)260928
• 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): 04/19/2026

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: 09/28/2026
• Device Catalogue Number: 12222-000-0002
• Device Lot Number: 1815.2806.24
• 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: 02/11/2026
• Supplement Report FDA Received Date: 04/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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