AVANOS MEDICAL INC. BALLARD CLOSED SUCTION SYSTEMS FOR NEONATES/PEDIATRICS, Y-ADAPTER; VAP CLOSED SUCTION CATHETERS & ACCESSORIES
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Model Number 196 |
Device Problem
Material Integrity Problem (2978)
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Patient Problems
Arrhythmia (1721); Low Oxygen Saturation (2477)
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Event Date 10/30/2023 |
Event Type
Injury
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 17 nov 2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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Event Description
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It was reported, a ¿ventilated patient [desatured] and [became bradycardic and] did not respond to administered oxygen supplement.¿ the decision was made to suction the child's trachea.It was noted that the respiratory therapist and nurse observed that 14cm of the protective sheath was ¿broken¿ and the catheter was exposed to ambient air; proper placement of the tube was confirmed.Additional information received 08nov2023 reported, the child was on a ventilator when the desaturation and bradycardia occurred.The patient¿s current condition was not reported.
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Manufacturer Narrative
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The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 20 dec 2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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Manufacturer Narrative
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The device history record for lot 30206497 was reviewed and the product was produced according to product specifications.The actual sample from the reported event was returned and evaluated.The root cause was identified and traced to the manufacturing process.All information reasonably known as of 16 jan 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
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