Model Number 1186000777T |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
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Event Description
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The customer reported that the syringe pops off the injector as the patient is being injected.There was no harm to the patient.
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Manufacturer Narrative
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After further review of the complaint details it was determined that this report was submitted in error as the incident does not meet the mdr regulation requirements of a reportable event.
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Manufacturer Narrative
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A review of the device history record did not indicate any exception that could lead to the reported incident.A sample was not returned to the manufacturing site for evaluation however the supplier conducted a visual check on the retained samples from the lot.There were no deviation deficiencies in any of components.The gasket was assembled and adhered to the plunger without any issue in all samples that were tested.The retained samples were then tested for suction by drawing the water into the syringe until the normal capacity and then injection.As result, no damage or detachment of the component (plunger, gasket) were detected during test.The root cause and corrective/preventative actions (capa) for the reported condition could not be determined based on the retained samples and lack of a returned sample from the customer.
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Search Alerts/Recalls
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