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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. JELCO® VIAVALVE® SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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SMITHS MEDICAL ASD; INC. JELCO® VIAVALVE® SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 326600
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 02/12/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Information was received indicating that upon removal of a smiths medical jelco® viavalve® safety iv catheter, the end came off and the catheter stayed in the vein.It was reported that bleeding had started around the insertion site and the iv was attempted to be removed.Subsequently, the catheter was then removed from the patient's skin.There were no further reported adverse effects.
 
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Brand Name
JELCO® VIAVALVE® SAFETY IV CATHETER
Common Device Name
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis,, mn
MDR Report Key9887347
Report Number3012307300-2020-02195
Device Sequence Number3318804
Product Code FOZ
UDI-Device Identifier10351688077431
UDI-Public10351688077431
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K113700
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/05/2021
Device Model Number326600
Device Catalogue Number326600
Device Lot Number3850522
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/24/2020
Initial Report FDA Received Date03/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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