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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. "VASCULAR" PACK, 30 CC SYRINGE SYRINGE, PISTON

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MEDLINE INDUSTRIES, INC. "VASCULAR" PACK, 30 CC SYRINGE SYRINGE, PISTON Back to Search Results
Model Number DYNJ49366
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/26/2019
Event Type  malfunction  
Event Description
Leur lock of the 30 cc syringe contained in the medline industries. Vascular pack, does not secure the heparin needle. This allows for the heparin needle to separate from the syringe while in use. Fda safety report id# (b)(4).
 
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Brand Name"VASCULAR" PACK, 30 CC SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
northfield IL 60093
MDR Report Key8907174
MDR Text Key154957091
Report NumberMW5089137
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Model NumberDYNJ49366
Device Catalogue NumberDYNJ49366
Device Lot Number19EBT109
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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