FDA Adverse Event Malfunction Summary report: N

MEDLINE SYRINGE, 10ML SALINE

MDR report key: 20300038 · Received September 25, 2024

Report

Report Number
20300038
Event Type
Malfunction
Date Received
September 25, 2024
Date of Event
April 5, 2024
Report Date
April 18, 2024
Manufacturer
MEDLINE INDUSTRIES, INC.
Product Code
NGT
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MO
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

MULTIPLE DEPARTMENTS BEGAN NOTICING AND REPORTING ON [REDACTED], THAT THE EXCELSIOR MEDICAL 10ML NORMAL SALINE FLUSH SYRINGE APPEARED TO BE CONTAMINATED. THE CONTAMINATION IS LOCATED ON THE OUTSIDE OF THE SYRINGE (BARREL), WHERE THE PLUNGER AND FLANGE MEET. WITHIN EACH SYRINGE WAS 0.9% CHLORIDE. THE MANUFACTURER, MEDLINE INDUSTRIES, INC., WAS NOTIFIED OF THESE INCIDENTS ON [REDACTED], AND SOME OF THE SYRINGES WERE PROVIDED TO THE MANUFACTURER ON THAT DATE. MEDLINE INDICATED THEIR INTENTION TO PERFORM TESTING ON THE PRODUCT, AND AT THEIR REQUEST, THE HOSPITAL PROVIDED FIVE ADDITIONAL SYRINGES ON[REDACTED]. ALL EXCELSIOR MEDICAL 10ML NS SYRINGES FROM AFFECTED LOTS (LOT NUMBERS: 24AJA030, 23JJA143, AND 23KJA112) WERE PULLED FROM HOSPITAL UNITS, AS WELL AS OUTPATIENT LOCATIONS, AND TAKEN TO HOSPITAL DISTRIBUTION. THESE WILL BE HELD AT OUR [REDACTED] WAREHOUSE UNTIL CREDIT IT ISSUED FROM MEDLINE. NO HARM HAS COME TO ANY PATIENTS AS OF THE DATE OF THIS REPORT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1303639 MEDLINE SYRINGE, 10ML SALINE SALINE, VASCULAR ACCESS FLUSH NGT MEDLINE INDUSTRIES, INC. EMZ11240 24AJA030

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown