MAUDE Adverse Event Report: EITAN MEDICAL LTD. AP424- MICROBORE WITH NON-VENTED SPIKE, FEMALE LUER LOCK WITH A BACK CHECK VALVE; ADMINISTRATION SET

Catalog Number 12003-000-0015

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/25/2023

Event Type  malfunction  

Event Description

The complaint was reported by a customer from france.Delivery issue.

Event Description

The complaint was reported by a customer from france.Delivery issue.

• Brand Name: AP424- MICROBORE WITH NON-VENTED SPIKE, FEMALE LUER LOCK WITH A BACK CHECK VALVE
• 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: 18300084
• MDR Text Key: 330141083
• Report Number: 3010293992-2023-00041
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12003-000-0015
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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