Catalog Number CS-14402 |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problems
Edema (1820); Extravasation (1842)
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Event Date 08/23/2020 |
Event Type
Injury
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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: "at night, a bolus of 5% albumin (30ml) is administered in half an hour through the right jugular central catheter.Healing of the very wet central catheter is striking, and it was decided to cure.When removing transparent dressing, edema is evidenced in the right anterior wall of the chest and neck with exit of parenteral nutrition due to surgical wound and central catheter insertion site, immediately inform the doctor and extravasation of parenteral nutrition to subcutaneous cellular tissue is considered.The administration of infusions through the catheter is suspended.After asepsis and antisepsis, a medical professional passes a left subclavian central bilumen catheter, the right jugular catheter is removed, but it is verified with a sterile technique that the catheter is broken along the way.The patient with integral skin, but with edema.The device had been in use for 6 days at the time of change, with no report of rupture during insertion, or previously associated problems." it was reported the patient presented edema in the right wall of the chest and neck with exit of parenteral nutrition due to a surgical wound and a central catheter insertion site.There was no serious or permanent damage.The catheter was removed.
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Event Description
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The complaint is reported as: "at night, a bolus of 5% albumin (30ml) is administered in half an hour through the right jugular central catheter.Healing of the very wet central catheter is striking, and it was decided to cure.When removing transparent dressing, edema is evidenced in the right anterior wall of the chest and neck with exit of parenteral nutrition due to surgical wound and central catheter insertion site, immediately inform the doctor and extravasation of parenteral nutrition to subcutaneous cellular tissue is considered.The administration of infusions through the catheter is suspended.After asepsis and antisepsis, a medical professional passes a left subclavian central bilumen catheter, the right jugular catheter is removed, but it is verified with a sterile technique that the catheter is broken along the way.The patient with integral skin, but with edema.The device had been in use for 6 days at the time of change, with no report of rupture during insertion, or previously associated problems." it was reported the patient presented edema in the right wall of the chest and neck with exit of parenteral nutrition due to a surgical wound and a central catheter insertion site.There was no serious or permanent damage.The catheter was removed.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.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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Search Alerts/Recalls
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