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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,ADMINISTRATION,INTRAVASCULAR
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CAREFUSION EXTENSION SET; SET,ADMINISTRATION,INTRAVASCULAR Back to Search Results
Model Number MP9251-C
Medical Device Problem Codes Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/19/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Patient demographics requested however not provided.
 
Event or Problem Description
It was reported that the user noticed blood saturated patient clothing, upon closer observation a minibore extension set hub broke off into the maxplus connector when attached to a broviac catheter.The user stated that it was unknown which set broke initially.
 
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Brand Name
EXTENSION SET
Common Device Name
SET,ADMINISTRATION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8725397
Report Number9616066-2019-01640
Device Sequence Number2003627
Product Code FPA
UDI-Device Identifier10885403237188
UDI-Public10885403237188
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K051499
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/28/2019
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
Operator of Device Health Professional
Device Model NumberMP9251-C
Device Catalogue NumberMP9251-C
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
BROVIAC CATHETER,MAXPLUS , TD (B)(6) 2019
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