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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MAXGUARD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION MAXGUARD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number ME1046
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/02/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.No investigation was performed.
 
Event or Problem Description
It was reported that the extension set broke off in the t-connector during the administration of rbcs while connected to a neonate.They were unable to remove the broken piece so they replaced the t-connector.There was no harm.
 
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Brand Name
MAXGUARD EXTENSION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8707431
Report Number9616066-2019-01676
Device Sequence Number13951196
Product Code FPA
UDI-Device Identifier10885403235986
UDI-Public10885403235986
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
K051499
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 05/29/2019
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 NumberME1046
Device Catalogue NumberME1046
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/18/2019
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
PRI TUBING, THERAPY DATE (B)(6) 2019
Patient Age1 MO
Patient Weight5
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