• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD EXT SET MICRO DEHP-FREE INTRAVASCULAR ADMINISTRATION SET

  • 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 SD EXT SET MICRO DEHP-FREE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 10031776
Device Problem Leak/Splash (1354)
Patient Problem Death (1802)
Event Date 09/10/2020
Event Type  Death  
Manufacturer Narrative
Date of death: the actual date of death is unknown. On (b)(6) 2020 has been used for this field. Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that as lvp 20d 3ss cv was used on a covid-19 positive patient who died. The following information was provided by the initial reporter: material no: 10031776 ; batch no: 20065112. It was reported that a product failure with item 10031776 may have resulted in a patient death. Bd rep response 14-sep-2020: "i spoke with (b)(6) at (b)(6) this past thursday and they do have one of the tubing sets that failed. Since this tubing was connected to a patient that was covid-19 positive, how do we go about sending that into bd?" customer response 11-sep-2020: "sending this request to the appropriate staff for information based on request below. " "i received a phone call from xxxxxxxxxxxx at (b)(6) health stating that there was a product failure with item 10031776 which may have resulted in a patient death. I spoke with her at 10:00 am regarding this event. Xxxxxxx is in supply chain at (b)(6) and can put us in touch with the end users who experienced the event and provide more detail. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEXT SET MICRO DEHP-FREE
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 s state st
sandy UT 84070 3213
Manufacturer Contact
brett wilko
9450 s state st
sandy, UT 84070-3213
8015652341
MDR Report Key10605984
MDR Text Key209153920
Report Number9616066-2020-02831
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number10031776
Device Catalogue Number10031776
Device Lot Number20065112
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/30/2020 Patient Sequence Number: 1
-
-