Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION STANDARDBORE PRESSURE RATED EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
  • 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
 

CAREFUSION STANDARDBORE PRESSURE RATED EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZXT5306
Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)
Patient Problem No Code Available (3191)
Event Date 10/01/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 18 gauge ultrasound guided extra-long iv catheter.No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.Race and ethnicity: white, non-hispanic.Medical history and admitting diagnosis was requested but not provided.
 
Event Description
It was reported that the valve of t-connector popped out during administration of ct scan iv contrast at 4ml/sec with 300psi.The iv contrast was administered through the distal end of the extension set.It was observed that the blood leaked out of the t-connector after the valve popped out.It was noted that because of the event, the patient received additional iv contrast and radiation.
 
Manufacturer Narrative
Photo provided by the customer shows the top cap of nac-t popped off allowing blood to leak.The root cause for this event could not be determined.
 
Event Description
It was reported that the valve of t-connector popped out during administration of ct scan iv contrast at 4ml/sec with 300psi.It was noted that the iv contrast was administered through the distal end of the extension set.It was observed that the blood leaked out of the t-connector after the valve popped out.It was noted that because of the event, the patient received additional iv contrast and radiation.
 
Event Description
It was reported that the valve of t-connector popped out during administration of ct scan iv contrast at 4ml/sec with 300psi.It was noted that the iv contrast was administered through the distal end of the extension set.It was observed that the blood leaked out of the t-connector after the valve popped out.It was noted that because of the event, the patient received additional iv contrast and radiation.
 
Manufacturer Narrative
Correction on initial report: d.1, d.4 & g.5.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STANDARDBORE PRESSURE RATED EXTENSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9227051
MDR Text Key164081839
Report Number9616066-2019-03009
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K171957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMZXT5306
Device Catalogue NumberMZXT5306
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/23/2019
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received12/19/2019
01/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PRESSURE INJECTOR, THERAPY DATE (B)(6) 2019.
Patient Age72 YR
Patient Weight76
-
-