MAUDE Adverse Event Report: EITAN MEDICAL LTD. AP504-01 UV RESISTANT INFUSION SET; ADMINISTRATION SET

Model Number	12000-000-0045
Medical Device Problem Code	Connection Problem (2900)
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.Suspected delivery issue and leakage.
Event or Problem Description
This complaint was reported by a customer from usa.Suspected delivery issue and leakage.

• Brand Name: AP504-01 UV RESISTANT INFUSION SET
• 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: 16402457
• Report Number: 3010293992-2023-00004
• Device Sequence Number: 14275184
• Product Code: FPA
• UDI-Device Identifier: 17290109153176
• UDI-Public: 17290109153176
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2023

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: Other
• Device Model Number: 12000-000-0045
• Device Catalogue Number: 12000-000-0045
• Device Lot Number: 0348.2906.10
• 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: 02/20/2023
• Supplement Report FDA Received Date: 04/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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