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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; SALINE, VASCULAR ACCESS FLUSH
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MEDLINE INDUSTRIES, INC. MEDLINE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Model Number EMZ111240
Patient Problem Insufficient Information (4580)
Event Date 01/26/2024
Event Type  malfunction  
Event Description
Situation: individually factory wrapped normal saline flush syringes were found to have fine particulate debris on syringe and inside packaging.Background: opi has been using individually wrapped normal saline flushes for many years.Assessment: the saline flush manufacturer had a quality control flaw.Recommendation: contact supplier and manufacturer to report event.Alert all health care units to inspect their normal saline flushes carefully before using.The particulate discovered is fine.Manufacturer response for saline flush syringes, saline flush syringes (per site reporter).Medline confirmed the product is a medline product and is going to work w/ [redacted name] to retrieve it.[redacted date] [redacted name] mailed product trk# (b)(4).
 
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Brand Name
MEDLINE
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key18885356
MDR Text Key337428333
Report Number18885356
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/19/2024
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 Model NumberEMZ111240
Device Lot Number23IJA053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/19/2024
Event Location Outpatient Treatment Facility
Date Report to Manufacturer03/12/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/12/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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