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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION TEXIUM CLOSED MALE LUER WITH FEMAILE CAP; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION TEXIUM CLOSED MALE LUER WITH FEMAILE CAP; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 10012241-0500
Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Patient age and dob requested but not provided.
 
Event Description
It was reported that the texium was unable to be attached to the patient.The texium would not thread appropriately and there were "shavings" of the texium still attached.The texium was replaced with a new texium which attached to the patient without difficulty.
 
Manufacturer Narrative
The customer¿s report that the texium was unable to be attached and that and there were "shavings" of the texium still attached was not confirmed.Visual inspection of the texium connector did not observe any shavings still attached to the texium.Functional and pressure testing resulted in no abnormalities.The set primed successfully with no leaks occurring at either of the connections to the texium connector.The set configuration was loaded into a lab syringe pump module for an infusion test.The primary infusion was programmed at a rate of 10ml/h and 10ml vtbi.The infusion completed with no alarms or leaks observed at both connections to the texium connector.The root cause of the customer¿s report was not identified.
 
Event Description
It was reported that the texium was unable to be attached to the patient.The texium would not thread appropriately and there were "shavings" of the texium still attached.The texium was replaced with a new texium which attached to the patient without difficulty.The customer later stated that there were no adverse effects caused to the patient from the event.
 
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Brand Name
TEXIUM CLOSED MALE LUER WITH FEMAILE CAP
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8736560
MDR Text Key149351344
Report Number9616066-2019-01722
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403221705
UDI-Public10885403221705
Combination Product (y/n)N
PMA/PMN Number
K053049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/30/2019
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
Device Operator Health Professional
Device Expiration Date02/21/2022
Device Model Number10012241-0500
Device Catalogue Number10012241-0500
Device Lot Number19026457
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/26/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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