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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE SYRINGE, PISTON

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MEDLINE INDUSTRIES, INC. MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE SYRINGE, PISTON Back to Search Results
Lot Number 200215
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/23/2020
Event Type  malfunction  
Event Description
Plastic sliver was found floating in barrel of syringe. Fda safety report id # (b)(4).
 
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Brand NameMEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
MDR Report Key10592674
MDR Text Key209021514
Report NumberMW5096892
Device Sequence Number1
Product Code FMF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number200215
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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