ST PAUL DELTEC POWER PORT-A-CATH, CATH II, AND P.A.S. POR; PORT, CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVA
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Model Number 21-4475-24 |
Device Problem
Device Slipped (1584)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A product sample was received for evaluation.A device history record (dhr) review was conducted using similar lots which indicated all inspections were completed and no issues were noted during manufacture.A review of the manufacturing process for a similar lot was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.Visual and functional testing were performed.No discrepancies were detected upon visual inspection and assembly of the unused samples received.Functional tests were performed on the sample to verify the catheter could detach easily.No discrepancies were found, the catheter kept on the port after pulling it.No discrepancies were found.Root cause cannot be determined since the complaint was not confirmed due to the fact the sample was successfully tested and no discrepancies were detected on visual inspection.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms (b)(4).
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Event Description
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It was reported that when the user pulled the catheter to combine it into the connector, the catheter slid out.No patient injury was reported.
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Search Alerts/Recalls
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