Catalog Number 4254511-02 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/12/2016 |
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: (b)(4): product: 4254511-02, lot 16c07g8291.Event description: pre-op nurse attempted to insert angiocath 22g braun introcan safety; as she withdrew needle from catheter after flashback of blood, the end of needle dislodged from plastic base.Nurse had to manually pull out needle from catheter; iv was removed from patient intact.New iv inserted without difficulty using same product.Picture taken of impaired angiocath.Sample not available.Picture received.
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Manufacturer Narrative
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(b)(4).This report has been identified as b.Braun medical internal report number (b)(4).Multiple unsuccessful attempts were made to obtain a sample.No sample was returned for evaluation; because of this, further investigation of the complaint is not possible and no conclusion could be drawn.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.Device history record (dhr): review of the device history records was performed and no non conformances or deviations were noted in process and final inspection.
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Search Alerts/Recalls
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