Model Number IPN918764 |
Device Problems
Contamination (1120); Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/19/2022 |
Event Type
malfunction
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Event Description
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It was reported that: "the incident occurred on (b)(6) 2022.On the distal line, there was no venous backflow.The doctor who inserted the access explained that when he aspired on the line, there was no blood backflow.He felt there was an obstruction.After insisting he observed a small foreign body, like a "little piece of plastic" going up along the line, then he had a blood backflow.".It was reported there was no consequence for the patient and no other device was used.The device remained in the patient at the time of this report.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported that: "the incident occurred on 19 february 2022.On the distal line, there was no venous backflow.The doctor who inserted the access explained that when he aspired on the line, there was no blood backflow.He felt there was an obstruction.After insisting he observed a small foreign body, like a "little piece of plastic" going up along the line, then he had a blood backflow.".It was reported there was no consequence for the "patient" and no other device was used.The device remained in the patient at the time of this report.
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Search Alerts/Recalls
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