Catalog Number 381023 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis (2100)
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Event Date 11/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the pediatric patient suffered from "venous thrombosis" and "thrombosis with onset of extension to the deep venous network of the arm" during use after the bd insyte¿ autoguard¿ bc shielded iv catheter had been placed.A "simple peripheral kt, polyionic infusion or closed catheter" was used to administer antibiotics to the patient as a result.The following information was provided by the initial reporter: "we are indeed very concerned about this series of 3 patients with venous thromboses on serial and close catheters whereas we do not normally see thromboses of this type in pediatrics." "the three problems encountered were superficial venous thromboses in 3 different patients (and thrombosis with onset of extension to the deep venous network of the arm), thromboses that occurred after catheterization.No chemotherapy.Simple peripheral kt, polyionic infusion or closed catheter for administration of antibiotics according to the patient.".
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Event Description
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It was reported that the pediatric patient suffered from "venous thrombosis" and "thrombosis with onset of extension to the deep venous network of the arm" during use after the bd insyte¿ autoguard¿ bc shielded iv catheter had been placed.A "simple peripheral kt, polyionic infusion or closed catheter" was used to administer antibiotics to the patient as a result.The following information was provided by the initial reporter: "we are indeed very concerned about this series of 3 patients with venous thromboses on serial and close catheters whereas we do not normally see thromboses of this type in pediatrics." "the three problems encountered were superficial venous thromboses in 3 different patients (and thrombosis with onset of extension to the deep venous network of the arm), thromboses that occurred after catheterization.No chemotherapy.Simple peripheral kt, polyionic infusion or closed catheter for administration of antibiotics according to the patient.".
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Manufacturer Narrative
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Bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.The complaint was deemed as mdr reportable therefore a submission will be performed.Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.This complaint will be closed at this time.
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Search Alerts/Recalls
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