SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. DELTEC STANDARD PROFILE PROPORT TRAY; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 21-4153-24 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2024 |
Event Type
Injury
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Event Description
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It was reported that the catheter detached from the port, and an emergency intervention was required to remove the catheter that had been displaced towards the heart.This occurred with two separate patients.The product was a single use product, used one time for two weeks.The occurrence of this issue was noticed after the insertion of the catheter.Two pictures of the x-rays of the patients were provided.The patients' genders are unknown, aged between 60 to 80 years and with cancer in their medical history.There was medical intervention to remove the catheter from the patients.There was no patient harm as a result of this event.
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Manufacturer Narrative
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Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation summary: two (2) photos were provided by the customer which were used to conduct the device analysis, the sample has not been received in the tijuana site.The reported fault was not found.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
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