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	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint was reported by a customer from the usa.Leakage issue.
Event or Problem Description
This complaint was reported by a customer from (b)(6).Leakage issue.
Additional Manufacturer Narrative
Investigation type: eitan medical inspected the photo provided by the customer and the lot history records of the set used by the customer during the event.Investigation findings: the complaint was confirmed based on the photo 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 and no additional complaints of this nature were received by eitan medical.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.

• 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: 20001768
• Report Number: 3010293992-2024-00043
• Device Sequence Number: 17971746
• Product Code: FPA
• UDI-Device Identifier: 17290109152223
• UDI-Public: (01)17290109152223(10)0787120713(17)251012
• 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,Followup
• Report Date (Section B): 05/08/2025

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: Health Professional
• Device Catalogue Number: 12222-000-0001
• Device Lot Number: 0787.1207.13
• 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; Not provided
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 10/15/2024; 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2023
• 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