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

Model Number 12000-000-0045

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

This complaint was reported by a customer from usa.Suspected delivery issue and leakage.

Event Description

This complaint was reported by a customer from usa.Suspected delivery issue and leakage.

• Brand Name: AP504-01 UV RESISTANT INFUSION SET
• Type of Device: 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
• MDR Text Key: 310087965
• Report Number: 3010293992-2023-00004
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 17290109153176
• UDI-Public: 17290109153176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1