MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ZR PRE-FILLED 10ML SALINE FLUSH SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number EMZ111240

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Information (3190)

Event Date 01/31/2019

Event Type  malfunction  

Event Description

Since the receipt and use of this product, staff have complained that the packaging is difficult to open, and removal of syringe cap is nearly impossible with only hand strength.To remove the cap, it requires the use of a device such as hemostat.Manufacturer response for 0.9% sodium chloride injection, usp 10ml in a 10ml flush syringe zr (per site reporter).Pending evaluation and response.

• Brand Name: ZR PRE-FILLED 10ML SALINE FLUSH SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8296531
• MDR Text Key: 134716734
• Report Number: 8296531
• 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: 01/31/2019

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 Operator: Other
• Device Model Number: EMZ111240
• Device Catalogue Number: EMZ111240
• Device Lot Number: 18LJA032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1