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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. SYRINGES BLOOD GLUCOSE SYSTEM

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TRIVIDIA HEALTH, INC. SYRINGES BLOOD GLUCOSE SYSTEM Back to Search Results
Model Number SYRINGES
Device Problem Moisture or Humidity Problem (2986)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/23/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product not yet returned for evaluation. Most likely underlying root cause: mlc-140- supplier manufacturing defect. Based on the post market review (b)(4) 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: a call back was made on (b)(6) 2017 to ensure that the replacement products resolved the initial concern; spoke with pharmacist they confirm replacement product was received and working as intended. Pharmacist stated that alleged defective product was not return for investigation. Made 2nd request to have products returned to complete our investigation. Return label will be sent for pick of product. Confirmed again with pharmacist that there were no adverse events occurred associated with product.
 
Event Description
Pharmacist called inquiring about a customer who had questions regarding if okay for syringes to be moist and used after opening package with moisture in the packaging. Informed pharmacist that he will need to inform customer to contact us for replacement of syringes by providing customer with customer care number to call regarding replacement.
 
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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 Key7969308
MDR Text Key123837292
Report Number1000113657-2018-01038
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 other
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYRINGES
Device Lot NumberMP16030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/16/2018 Patient Sequence Number: 1
Treatment
SECOND THERAPY
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