ST PAUL DELTEC VALVED PEEL-AWAY SHEATH INTRODUCER; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCU
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Model Number 21-4477-24 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Three (3) ports were received for evaluation.Samples were visually inspected at a distance of 12" to 16" under normal conditions of illumination.The catheter received is bigger than required; the failure mode was confirmed.It can be concluded that the most likely root cause is during the packaging process (pick and place) of the catheter, the line clarence process was not properly followed.A nonconformance report (ncr) was released in order to evaluate the investigation and determine the correction action required.A device history record (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.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 the catheter was too big to attach to the port.No patient injury was reported.
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Search Alerts/Recalls
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