ST PAUL PORT-A-CATH IMPLANTABLE ACCESS SYSTEM; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV
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Catalog Number 21-4483-24 |
Device Problems
Detachment of Device or Device Component (2907); Separation Problem (4043)
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Patient Problem
Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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B3: date of event is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that a patient had a port a cath placed on (b)(6)2020.On (b)(6)2023 medical facility notes indicates the following: patient for cvc mediport flush in fast track.Port in r chest accessed without difficulty, no blood return after 1 cc flush, flushed with 4 cc of nss and area above port access became edematous and cool to touch?.Patient denied pain with flushing, but slight discomfort with palpitation of area.Charge rn and np notified for assessment.Stat chest x-ray was ordered, and the port de-accessed.Chest x-ray results: there is a right sided mediport.There is a separation of the catheter from the port measuring 1.1 cm.There is no distal migration of the catheter.The catheter tip overlies the svc.Patient was transferred to the ed where the port a cath was removed bedside by the surgeon.Adverse patient effects are unknown.
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Manufacturer Narrative
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Other, other text: g1,2 email is: regulatory.Responses@icumed.Com.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
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Search Alerts/Recalls
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