COVIDIEN MFG SOLUTIONS S.A. PERITONEAL CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING
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Model Number PERITONEAL CATHETER |
Device Problems
Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Hernia (2240)
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Event Date 08/24/2022 |
Event Type
Injury
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Event Description
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According to the literature, a retrospective study from 2019 to 2022 evaluated the placement and use of peritoneal dialysis (pd) catheters in the neonate population.The swan neck curl catheter with double cuffs was placed in 85 neonates.Before use, heparin, antibiotic and potassium chloride based on the patient¿s blood potassium level were added to the dialysis fluid.Among 28 surviving infants, 5 had completely recovered while in the neonatal intensive care unit (nicu) and the peritoneal dialysis (pd) catheters were removed.The remaining 23 patients were transferred to general pediatric ward to be followed by pediatric nephrology unit.Among the 85 patients, 28 survived and 57 died due to the related underlying causes, rather than complications of peritoneal dialysis (pd).
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Manufacturer Narrative
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Concomitant product: unk pd - peritoneal catheter, lot# unknown unk pd - peritoneal catheter, lot# unknown title: acute peritoneal dialysis in the newborn: a safe and feasible method source: https://doi.Org/10.1016/j.Jpedsurg.2022.08.021 accepted (b)(6) 2022 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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