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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORPORATION MAXGUARD PRE-SLIT INJECTION PORT
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CAREFUSION CORPORATION MAXGUARD PRE-SLIT INJECTION PORT Back to Search Results
Model Number 1000M
Device Problems Fluid/Blood Leak (1250); Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The customer reported the split septum is not sealing tightly around the catheter.Fluid leaked around the 18g blunt cannula during a normal saline push.There was no pt/staff harm and medical intervention was not reported.No further pt or event info was provided.
 
Manufacturer Narrative
(b)(4).This report was filed by the mfr.The affected product has been received.A follow up report will be submitted with investigation results once the evaluation has been completed.
 
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Brand Name
MAXGUARD PRE-SLIT INJECTION PORT
Manufacturer (Section D)
CAREFUSION CORPORATION
san diego CA
Manufacturer Contact
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121
8586176477
MDR Report Key3728306
MDR Text Key17841745
Report Number9616066-2014-00193
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/18/2014
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 Number1000M
Device Catalogue Number1000M
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/25/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/18/2014
Initial Date FDA Received03/05/2014
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
Treatment
THERAPY DATE; COVIDIEN MONOJECT 18 GAUGE BLUNT CANNULA; PART #8881202017, LOT UNK
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