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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. PISTON SYRINGE SYRINGE, PISTON

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MEDLINE INDUSTRIES INC. PISTON SYRINGE SYRINGE, PISTON Back to Search Results
Model Number DYND20325
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem Insufficient Information (4580)
Event Date 08/30/2021
Event Type  malfunction  
Event Description
Sterile piston syringe has hair-like appearing item within the sterile packaging (never opened). Fda safety report id # (b)(4).
 
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Brand NamePISTON SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
northfield IL 60093
MDR Report Key12421430
MDR Text Key270098953
Report NumberMW5103704
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDYND20325
Device Catalogue NumberDYND20325
Device Lot Number96921010001
Was Device Available for Evaluation? Yes
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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