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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX DURAFLEX PLUS WIRE REINFORCED CATHETERS ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. PORTEX DURAFLEX PLUS WIRE REINFORCED CATHETERS ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 4917M-19
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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Brand NamePORTEX DURAFLEX PLUS WIRE REINFORCED CATHETERS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15316102
Report Number3012307300-2022-16603
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00351688047574
UDI-Public00351688047574
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4917M-19
Device Catalogue Number4917M-19
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/12/2022
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

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