Catalog Number 38831114 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
Pain (1994)
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Event Date 01/25/2024 |
Event Type
malfunction
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Event Description
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It was reported that bd insyte needle pierce the catheter.The following information was provided by the initial reporter, translated from spanish to english: customer has quality problems with insyte catheters 24ga x 0.75.As you can see in the pictures the catheter breaks and detaches from the needle.It hurts the patient and the cannulation is not performed correctly, additionally in other cases the product is not used due to defective input.
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Manufacturer Narrative
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H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Event Description
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Response received on 19feb2024.Has there been any harm to the patient/health professional (detail)? it was not possible to take the sample due to the conditions of the input.Was there a need for medical and/or surgical intervention due to the incidence (imaging tests, surgery, drug administration, etc.)? (detail) no.
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Manufacturer Narrative
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Additional information received regarding patient outcome.See tab b description.
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Search Alerts/Recalls
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