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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 SR-FVP2416PS
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/25/2018
Event Type  malfunction  
Manufacturer Narrative
The product was not returned, so a detailed analysis could not be conducted however pictures of the shelf pack boxes with the torn / stuck label were sent back and examined. Based on a visual examination of the pictures, it is apparent that the box label from one shelf pack box became adhered to another shelf pack box. It is most likely that this could have occurred during the packaging process and that the label from one box was not fully adhered to the shelf pack box when it was placed in the shipper box. Smiths medical personnel has been made aware of this incident. Smiths medical will continue monitoring complaints and will performed corrective actions accordingly.
 
Event Description
It was reported that when the customer opened the outer box of the jelco safety via valve catheters, they picked up the inner box and noticed that a part of the indication label was stuck to a neighboring inner box. The label was also torn. No damage was observed in the outer box.
 
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Brand NameJELCO SAFETY VIAVALVE CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
201 west queen street
southington CT 06489
Manufacturer Contact
dave halverson
1265 grey fox road
st. paul, MN 55112
7633833310
MDR Report Key7716036
MDR Text Key114936068
Report Number3012307300-2018-02908
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 07/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/13/2020
Device Catalogue NumberSR-FVP2416PS
Device Lot Number3588635
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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