MAUDE Adverse Event Report: EITAN MEDICAL LTD. AP240-01 - MICROBORE WITH NON-VENTED SPIKE, 1.2M FILTER AND BACK CHECK VALVE; ADMINISTRATION SET

Catalog Number	12003-000-0069
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint was reported by a customer from usa.Leakage issue.

• Brand Name: AP240-01 - MICROBORE WITH NON-VENTED SPIKE, 1.2M FILTER AND BACK CHECK 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: 21582812
• Report Number: 3010293992-2025-00018
• Device Sequence Number: 9457048
• Product Code: FPA
• UDI-Device Identifier: 17290109155132
• UDI-Public: (01)17290109155132(10)1355240614(17)261224
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141834
• 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
• Report Date (Section B): 03/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: 12003-000-0069
• Device Lot Number: 1355.2406.14
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2025
• Date Device Manufactured: 06/24/2024
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown