MalfunctionOFF
MEDLINE CENTRAL LINE PACK
Received Jun 12, 2024 · Event occurred Sep 1, 2023
Report 19519008 · MDR key 19519008
Device
Generic name
Central Venous Catheter Tray
Manufacturer
Medline Industries, Inc.Model number
DYNJ24720BCatalog number
DYNJ24720B
Lot number
23CDA317
Patient
3 MO · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
HEMOSTAT THAT CAME IN LINE KIT WAS BEING USED AND THE TIP OF ONE SIDE OF THE HEMOSTAT BROKE OFF DURING USE. MANUFACTURER RESPONSE FOR HEMOSTAT, MEDLINE (PER SITE REPORTER). THEY RESPONDED SAYING- FINDINGS: BASED ON THE COMPLAINT DETAILS THE ROOT CAUSE IS CONSIDERED TO BE A VENDOR PRODUCT ISSUE RELATING TO THE COMPONENT MANUFACTURING PROCESS. ACTIONS TAKEN AND RECOMMENDATIONS: THIS COMPLAINT HAS BEEN PROVIDED TO THE COMPONENT MANUFACTURING FACILITY FOR FURTHER EVALUATION.