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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAFETY VIAVALVE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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SMITHS MEDICAL ASD, INC. JELCO SAFETY VIAVALVE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 326510
Medical Device Problem Codes Product Quality Problem (1506); Dull, Blunt (2407)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
 
Event or Problem Description
It was reported that the staff were experiencing difficulty starting the ivs.The catheters appeared dull and failed to advance.It was further reported that the patients experienced pain upon insertion.No further complication were reported, and no medical intervention was provided.
 
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Brand Name
JELCO SAFETY VIAVALVE CATHETER
Common Device Name
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7782570
Report Number3012307300-2018-03247
Device Sequence Number13832314
Product Code FOZ
UDI-Device Identifier15019517078411
UDI-Public15019517078411
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K160235
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/30/2020
Device Catalogue Number326510
Device Lot Number3578512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/18/2018
Initial Report FDA Received Date08/14/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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