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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TANDEM / UNOMEDICAL DEVICES S.A. DE C.V. AUTOSOFT 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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TANDEM / UNOMEDICAL DEVICES S.A. DE C.V. AUTOSOFT 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 5262078
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2019
Event Type  Injury  
Event Description
Cannula of infusion set gets folded over due to residual torque and or bad nesting in insertion device. Lack of insulin delivery. Fda safety report id# (b)(4).
 
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Brand NameAUTOSOFT 90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
TANDEM / UNOMEDICAL DEVICES S.A. DE C.V.
MDR Report Key8631778
MDR Text Key145898503
Report NumberMW5086800
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2021
Device Lot Number5262078
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

Patient Treatment Data
Date Received: 05/21/2019 Patient Sequence Number: 1
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