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 BLOOD COLLECTION DEVICE
  • 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 BLOOD COLLECTION DEVICE Back to Search Results
Model Number MBC6010
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2015
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.
 
Event Description
The customer reported that the septum from mbc6010 separated and was retained inside a blood culture bottle.There is no report of patient harm.
 
Manufacturer Narrative
Correction to initial reporter address.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BLOOD COLLECTION DEVICE
Type of Device
BLOOD COLLECTION
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key5001770
MDR Text Key22944864
Report Number9616066-2015-00978
Device Sequence Number1
Product Code KST
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Followup
Report Date 07/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMBC6010
Device Catalogue NumberMBC6010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/22/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-