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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TRAY EPID SST18G3.5 S/L ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC TRAY EPID SST18G3.5 S/L ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 406069
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that the tray epid sst18g3. 5 s/l came with a metal-tipped glass syringe instead of the correct glass-tipped syringe. The following information was provided by the initial reporter: "it is supposed to have a glass syringe with a glass tip as noted on the package. The tray is coming with a glass syringe with a metal tip and per the physician ¿ cannot be used for these procedures. (huge safety issue)".
 
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Brand NameTRAY EPID SST18G3.5 S/L
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer (Section G)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11458176
MDR Text Key240672172
Report Number1625685-2021-00022
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904060695
UDI-Public00382904060695
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
DISCRETION
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number406069
Device Catalogue Number406069
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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