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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DYNAREX CORP. SYRINGES (W/O NEEDLE) SYRINGE, PISTON

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DYNAREX CORP. SYRINGES (W/O NEEDLE) SYRINGE, PISTON Back to Search Results
Model Number 6991
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2018
Event Type  malfunction  
Event Description
Multiple complaints from doctors regarding new 20 cc syringes by dynarex. While using to prep angioplasty balloons, plunger coming out of syringe, too flimsy.
 
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Brand NameSYRINGES (W/O NEEDLE)
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
DYNAREX CORP.
10 glenshaw st
orangeburg NY 10962
MDR Report Key7407258
MDR Text Key104731541
Report Number7407258
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Model Number6991
Device Lot Number32450
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/14/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer03/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/09/2018 Patient Sequence Number: 1
Treatment
ANGIOPLASTY BALLOONS
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