Model Number IPN048027 |
Device Problem
Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that the lor syringe contained in the pdk set falls apart during use.
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Event Description
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It was reported that the lor syringe contained in the pdk set falls apart during use.
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Manufacturer Narrative
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Qn#: (b)(4).A device history record review was performed based on potential lot numbers provided by the customer.A device history record review was performed on the lor nr fit syringe with no relevant findings.A review of design change history for kit ot19tkpss and part number: kz-05501-002n was performed as a part of this investigation.No design changes have been made to this product in the past two years that would have led to this complaint.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed based on potential lot numbers provided by the customer.A device history record review was performed on the lor nr fit syringe with no relevant findings.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.
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Search Alerts/Recalls
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