Catalog Number PR-35052-HPSM |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The complaint is reported as: ct tech states the injector has alarmed (close to pressure limit, which then causes the injection rate to slow) or pressured out and stopped the injection while using an arrow picc line at 5ml/s.The injection was given through the proximal line.It was reported there was no catheter leak or deformity of the extension line.No medical intervention required.The catheter was not replaced, the ct machine slowed down below 5ml/sec.The patient's condition is reported as fine.
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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.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.One finding was identified.A non-conformance was initiated for lot 13c21g1741 in regards to extension line leak during use.It cannot be determined if this is relevant to the customer report without a sample returned for evaluation.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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The complaint is reported as: ct tech states the injector has alarmed (close to pressure limit, which then causes the injection rate to slow) or pressured out and stopped the injection while using an arrow picc line at 5ml/s.The injection was given through the proximal line.It was reported there was no catheter leak or deformity of the extension line.No medical intervention required.The catheter was not replaced, the ct machine slowed down below 5ml/sec.The patient's condition is reported as fine.
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Search Alerts/Recalls
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