MAUDE Adverse Event Report: JUNG RIM MEDICAL INDUSTRIAL CO., LTD. CAREPOINT; 5ML LUER LOCK SYRINGE

Catalog Number 04-0005

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

Poly hub is not staying attached to the syringe.

• Brand Name: CAREPOINT
• Type of Device: 5ML 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: 18913478
• MDR Text Key: 337774495
• Report Number: 1000138447-2024-00002
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00786227040554
• UDI-Public: 00786227040554
• 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: 03/15/2024,02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04-0005
• Device Lot Number: 220405
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2024
• Distributor Facility Aware Date: 02/23/2024
• Device Age: 22 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/15/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1