MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. EXCELSIOR; SALINE, VASCULAR ACCESS FLUSH

Lot Number 3130118

Device Problems Contamination (1120); Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 02/12/2018

Event Type  malfunction  

Event Description

Multiple times when this product is used staff is not able to open it in a sterile fashion.The package tears in a manner that does not allow the product to come out of the packaging without it being contaminated.Packages are available.

• Brand Name: EXCELSIOR
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7326791
• MDR Text Key: 101990616
• Report Number: 7326791
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2018

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: No Information
• Device Expiration Date: 03/01/2019
• Device Lot Number: 3130118
• Other Device ID Number: 01 00363807100916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES