• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIVIDIA HEALTH INC SYRINGES PISTON SYRINGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TRIVIDIA HEALTH INC SYRINGES PISTON SYRINGE Back to Search Results
Model Number SYR, NPD 1.0CC 30G 100CT5/16" 8/CS
Device Problems Crack (1135); Material Twisted/Bent (2981)
Patient Problem Pain (1994)
Event Date 04/07/2021
Event Type  Injury  
Manufacturer Narrative
Internal report reference number: (b)(4). Adverse event report is being submitted due to customer experiencing pain when using syringes. Syringes were not returned for evaluation - customer had discarded product. Note: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.
 
Event Description
Consumer reported complaint for the trueplus syringes. Cardinal health reported complaint on behalf of the customer. The customer reported that the syringes were cracked, the 30g needles were bent and that pain had been experienced upon insertion. No medical attention associated with the use of the product was reported. Technician had attempted follow-up with customer had was unable to contact via telephone.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYRINGES
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
TRIVIDIA HEALTH INC
2400 nw 55th court
fort lauderdale FL 33309
Manufacturer Contact
karen devincent
2400 nw 55th court
fort lauderdale, FL 33309
MDR Report Key11793995
MDR Text Key250777121
Report Number1000113657-2021-00304
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYR, NPD 1.0CC 30G 100CT5/16" 8/CS
Device Lot NumberNP20104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/12/2021
Event Location No Information
Date Manufacturer Received06/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/07/2021 Patient Sequence Number: 1
-
-