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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAFETY VIAVALVE CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

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SMITHS MEDICAL ASD, INC. JELCO SAFETY VIAVALVE CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L Back to Search Results
Model Number 326010
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Only the month ((b)(6)) and year (2020) of the aware date are known.
 
Event Description
It was reported that the operator had an issue with the dimensions/length of the jelco safety protect iv catheter via valve iv safety catheter. The customer facility alleged that the product did not function as intended and was difficult to use. The product was 12 cm in length with the needle down to hub is 4. 5 cm. The additional length of 4 cm makes the iv catheter hard to maneuver and control for not only what would seem easy sticks, but it makes it extremely hard for difficult areas to access. Multiple catheters have to be used on patients to obtain iv access. The sites that have been accessed are infiltrating which can cause anesthesia med to infiltrate tissue. This can in turn cause issues for the patient because the meds could cause ulcerations around the site. The needle has also not pulled back into the safety area after making the click thus causing staff to almost be stuck by the dirty needle. The training arms that were used to demonstrate and practice the technique were not realistic with perfect veins.
 
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Brand NameJELCO SAFETY VIAVALVE CATHETERS
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
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
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10951349
MDR Text Key219881026
Report Number3012307300-2020-12142
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 12/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number326010
Device Catalogue Number326010
Device Lot Number4018990
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/05/2020
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

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