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

Catalog Number	04-0005
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Poly hub is not staying attached to the syringe.

• Brand Name: CAREPOINT
• Common Device Name: 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
• Report Number: 1000138447-2024-00002
• Device Sequence Number: 6892474
• Product Code: FMF
• UDI-Device Identifier: 00786227040554
• UDI-Public: 00786227040554
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/23/2024
• Report Date (Section F): 03/15/2024

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: Health Professional
• Device Catalogue Number: 04-0005
• Device Lot Number: 220405
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/23/2024
• Device Age: 22 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/15/2024