MAUDE Adverse Event Report: AZER SCIENTIFIC INC. BUFFERED SALINE SOLUTION 0.85%; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number ES45044

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

[sterile buffered saline specimen container] use for covid-19 under emergency use authorization (eua): the containers with the sterile buffered saline in it was found with the cap not on completely and the saline solution had leaked out of the container.Fda safety report id# (b)(4).

• Brand Name: BUFFERED SALINE SOLUTION 0.85%
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): AZER SCIENTIFIC INC.; morgantown PA 19543
• MDR Report Key: 13205482
• MDR Text Key: 283594676
• Report Number: MW5106523
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/05/2022

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 Operator: Health Professional
• Device Expiration Date: 04/10/2022
• Device Model Number: ES45044
• Device Lot Number: 26858
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1