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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCULAR POSITIONING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR
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VASCULAR POSITIONING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Catalog Number VPS-G4C
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/09/2016
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4).No sample will be returned for evaluation.
 
Event Description
It was reported the catheter was placed into the patient with the use of vps.The clinician had good p-wave and strong doppler and a blue bullseye was received.After the line was in place for some time the patient needed an x-ray.The x-ray showed the picc was not in the proper location for a blue bullseye.There was no patient death or complications reported.The case was already deleted from the vps console.The customer would not share the x-ray showing where the catheter tip was located.No additional information is available.
 
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Brand Name
VASCULAR POSITIONING SYSTEM
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5733219
MDR Text Key47671160
Report Number3003898360-2016-00679
Device Sequence Number1
Product Code OBJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123813
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 06/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberVPS-G4C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/09/2016
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 Sequence Number1
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