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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRVASCULAR
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CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRVASCULAR Back to Search Results
Model Number 20128E
Device Problems Break (1069); Separation Failure (2547)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
 
Event Description
The customer reported that the tubing broke off inside the central line catheter and the patient had to have their central line replaced.There is no report of lasting patient harm.
 
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Brand Name
ALARIS EXTENSION SET
Type of Device
SET, EXTENSION, INTRVASCULAR
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 Key6152680
MDR Text Key61662682
Report Number9616066-2016-01670
Device Sequence Number1
Product Code FPB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K801614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Other
Type of Report Initial
Report Date 11/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/01/2019
Device Model Number20128E
Device Catalogue Number20128E
Device Lot Number16066011
Was Device Available for Evaluation? No
Date Manufacturer Received11/09/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/11/2016
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
CENTRAL LINE CATHETER
Patient Outcome(s) Other;
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