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	07/17/2024
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 usa.Leakage issue.
Additional Manufacturer Narrative
Investigation type: eitan medical investigated a set from the same type and lot as the one used in the event, along with the original pump used.Investigation findings: the complaint was not confirmed.Both the set from the same type and lot as the one used in the event and the original pump used 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.
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.

• 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: 20006032
• Report Number: 3010293992-2024-00044
• Device Sequence Number: 15244744
• Product Code: FPA
• UDI-Device Identifier: 17290109152223
• UDI-Public: (01)17290109152223(10)0787250413(17)250725
• 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: 0787.2504.13
• 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): Yes
• Date Device Manufactured: 04/25/2023
• 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