MAUDE Adverse Event Report: JUNG RIM MEDICAL INDUSTRIAL CO., LTD. CAREPOINT; 3ML LUER LOCK SYRINGE

Model Number 13227-501-00

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/22/2022

Event Type  malfunction  

Event Description

The luer connectors are not working with needleless adaptors and are damaging some of them.

• Brand Name: CAREPOINT
• Type of Device: 3ML LUER LOCK SYRINGE
• Manufacturer (Section D): JUNG RIM MEDICAL INDUSTRIAL CO., LTD.; #593-81, sagok-ri, iwol-myeon; jincheon-gun, chungbuk 365-8 20; KS 365-820
• MDR Report Key: 17121465
• MDR Text Key: 317215349
• Report Number: 1000138447-2023-00007
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/02/2022,06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13227-501-00
• Device Catalogue Number: 04-0003
• Device Lot Number: 210602
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1