• 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 BLOOD GLUCOSE SYSTEM

  • 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 BLOOD GLUCOSE SYSTEM Back to Search Results
Model Number SYRINGES
Device Problem Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/26/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product not returned for evaluation. Customer misplaced the alleged defective product. Most likely underlying root cause: mlc-140- supplier manufacturing defect. Based on the post market review syr-pmr-100 and review of the fda's total product life cycle (tplc) - total device problems, for possible delay in administration of insulin. Reference - capa (b)(4). Note: manufacturer contacted customer on 10/10/2016 in a follow-up call to ensure that the replacement products resolved the initial concern; spoke with the pharmacist who states they have received the products and are satisfied. Pharmacist states the customer did not return the product and will contact customer in order to send back the original syringes. Product notification letter sent to customer to contact customer care. Manufacturer contacted pharmacy on 10/25/2016 in a follow-up call;spoke with the pharmacist who states that customer misplaced the syringes and does not know where they are. Customer received the replacement syringes and did not return the allegedly defective product.
 
Event Description
Pharmacist called and states that a customer came in with a box of syringes that were purchased at the pharmacy and all the needle of the syringes were bent. Pharmacy states they could not replace the syringes to the customer due to not having any more in stock and states the customer took the syringes home. I advised the pharmacist to contact the customer in order to retrieve the syringes and have them replaced. Instructed pharmacist to inform the customer not to use the product add that a new box will be shipped.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYRINGES
Type of DeviceBLOOD GLUCOSE SYSTEM
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
954677-920
MDR Report Key7973642
MDR Text Key123967382
Report Number1000113657-2018-01051
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K993017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Remedial Action Replace
Type of Report Initial
Report Date 10/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYRINGES
Device Lot NumberNP16082
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Home
Date Manufacturer Received10/04/2018
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: 10/17/2018 Patient Sequence Number: 1
Treatment
SECOND THERAPY
-
-