MAUDE Adverse Event Report: EXCELSIOR MEDICAL LLC 10ML SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number EMZ111240

Patient Problem Chemical Exposure (2570)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

Situation: malfunctioning flush syringe.Background: np 14 rn prepping to flush patient¿s line.Positive blood return, so went to flush but fluid sprayed all over rns arm and over patient.Syringe still completely connected to line and blood noted to be in barrel of syringe.Assessment: rn cleaned herself/pt and confiscated syringe.Recommendation: syringe lot number obtained for further investigation.

• Brand Name: 10ML SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): EXCELSIOR MEDICAL LLC; 1933 heck ave; neptune NJ 07753
• MDR Report Key: 18893104
• MDR Text Key: 337534899
• Report Number: 18893104
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2024

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
• Device Catalogue Number: EMZ111240
• Device Lot Number: 3143499
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1