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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AZER SCIENTIFIC, INC BUFFERED SALINE SOLUTION 0.85% SPECIMEN CONTAINER; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
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AZER SCIENTIFIC, INC BUFFERED SALINE SOLUTION 0.85% SPECIMEN CONTAINER; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL Back to Search Results
Lot Number 26533
Device Problems Fluid/Blood Leak (1250); Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2021
Event Type  malfunction  
Event Description
[sterile buffered saline] use for covid-19 under emergency use authorization (eua): the specimen container is leaking the 0.85% saline solution after swab has been placed and it is sent for processing.Over 100 plus patients have required retesting for covid due to the leaking of this product.Packages have been found with the specimen container not having enough saline in it moisture in the bag, as well as the specimens being rejected by the processing lab due to moisture and visible liquid outside of the specimen container.The items in the kit are prepackaged by the company for use by the institution.The specimen container with the medium is what we are having issues with.Fda safety report id # (b)(4).
 
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Brand Name
BUFFERED SALINE SOLUTION 0.85% SPECIMEN CONTAINER
Type of Device
CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
Manufacturer (Section D)
AZER SCIENTIFIC, INC
morgantown PA 19543
MDR Report Key13176559
MDR Text Key283479665
Report NumberMW5106480
Device Sequence Number1
Product Code JSG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/04/2022
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 Operator Health Professional
Device Lot Number26533
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/05/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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