SMITHS MEDICAL ASD, INC. JELCO SAFETY VIAVALVE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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Catalog Number SR-FVP2416PS |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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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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Search Alerts/Recalls
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