MAUDE Adverse Event Report: EITAN MEDICAL LTD. AVOSET 250ML CARTRIDGE US; ADMINISTRATION SET

Catalog Number	12222-000-1016
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation type: eitan medical inspected pictures received and the lot history records.Investigation findings: no discrepancies that may have caused or contributed to a complaint of this nature were identified.The investigation is ongoing.Conclusion: eitan medical requested unused cartridges of the same lot (1346.1207.15) 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.The customer reported that no human harm occurred.The only medical intervention described was a cassette replacement.
Event or Problem Description
This complaint was reported by a customer from usa.A leakage issue was reported.The customer reported that no human harm occurred.The only medical intervention described was a cassette replacement.
Additional Manufacturer Narrative
Investigation type: eitan medical inspected and tested cartridges from the same lot.Investigation findings: the leakage reported by the customer was not reproduced.Visual inspection confirmed a visual cosmetic kink/bent condition in the returned cartridges from the same customer, yet this did not result in any performance issue.The kink most probably occurred during the post-production phase.Conclusion: the visual kink issue is not a trend and not related to harm or performance issue.The leakage itself was not related to the identified visual cosmetic kink.Corrective actions were employed to reduce such potential visual cosmetic kink in the future.

• Brand Name: AVOSET 250ML CARTRIDGE US
• 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: 23987994
• Report Number: 3010293992-2026-00003
• Device Sequence Number: 14591134
• Product Code: FPA
• UDI-Device Identifier: 17290109152704
• UDI-Public: (01)17290109152704(10)1346120715(17)260712
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 07/12/2026
• Device Catalogue Number: 12222-000-1016
• Device Lot Number: 1346.1207.15
• 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: 01/07/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2025
• 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