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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SODIUM CHLORIDE 0.9% 10ML FLUSH; SALINE, VASCULAR ACCESS FLUSH
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SODIUM CHLORIDE 0.9% 10ML FLUSH; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Lot Number 1097432
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2021
Event Type  malfunction  
Event Description
Patient observed insect inside of product packaging (sodium chloride 0.9% 10ml flush for iv), did not use, complained to pharmacy.
 
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Brand Name
SODIUM CHLORIDE 0.9% 10ML FLUSH
Type of Device
SALINE, VASCULAR ACCESS FLUSH
MDR Report Key12665526
MDR Text Key278080817
Report NumberMW5104794
Device Sequence Number1
Product Code NGT
UDI-Device Identifier08290306546
UDI-Public08290-3065-46
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 10/18/2021
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 Date03/31/2024
Device Lot Number1097432
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/19/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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