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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HIGH-FLO SUB-Q SINGLE NEEDLE 26GX9MM SET, ADMINISTRATION, INTRAVASCULAR

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HIGH-FLO SUB-Q SINGLE NEEDLE 26GX9MM SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2019
Event Type  Injury  
Event Description
Spoke with pt's husband, (b)(6), who stated that pt did not receive supplies with last order.
 
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Brand NameHIGH-FLO SUB-Q SINGLE NEEDLE 26GX9MM
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key9349263
MDR Text Key167383480
Report NumberMW5091204
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 11/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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

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