MAUDE Adverse Event Report: EXCELSIOR MEDICAL LLC ZR FLUSH; SALINE, VASCULAR ACCESS FLUSH

Lot Number 3140730

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 04/21/2022

Event Type  malfunction  

Event Description

5 ml prefilled sterile syringes.Two syringes were found empty with plunger still fully extended.One leaked when attempting to flush a med line.Syringes appear to have cracks.

• Brand Name: ZR FLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): EXCELSIOR MEDICAL LLC; 1933 heck ave; neptune NJ 07753
• MDR Report Key: 14353099
• MDR Text Key: 291364990
• Report Number: 14353099
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/04/2022

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 Lot Number: 3140730
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1