Catalog Number MEDICAL UNKNOWN |
Device Problem
Physical Resistance (2578)
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Patient Problem
No Information (3190)
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Event Date 08/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
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Event Description
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The syringe does not provide immediate resistance when it should and it is not easy to use for detecting loss of resistance.The patient's condition was reported as unknown.
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Manufacturer Narrative
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(b)(4).A device history record review could not be performed as no product code or lot number was provided.Visual inspection could not be performed as no sample was returned for analysis.A photo of the device was returned for analysis.However, the complaint could not be confirmed based upon the photo received.A corrective action is not required at this time as the potential cause of difficulty finding loss of resistance could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as no product code or lot number was provided.Therefore, the potential cause of difficulty finding loss of resistance could not be determined based upon the information provided and without a sample.
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Event Description
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The syringe does not provide immediate resistance when it should and it is not easy to use for detecting loss of resistance.The patient's condition was reported as unknown.
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Search Alerts/Recalls
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