Catalog Number 4251652-02 |
Device Problems
Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/29/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
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Event Description
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As reported by the user facility: event: iv started without difficulty, upon removal of the needle the safety mechanism engaged at the "base" of the needle, did not cover the tip of the needle.No samples saved, no injury.
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Manufacturer Narrative
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(b)(4).The actual device was not returned for evaluation.Without the actual sample, a thorough investigation could not be performed.A historical review of the complaint database identified no adverse trends for product code 4251652-02 or lot number involved.If a sample and/or additional pertinent information becomes available, a follow up will be submitted.
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Search Alerts/Recalls
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