AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT - 22 FR, 3.0 CM - 45 - NON-ENFI; DH EF BALLOON TUBES PRODUCTS
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Model Number 0270-22-3.0-45 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problems
Nausea (1970); Vomiting (2144)
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Event Date 09/17/2020 |
Event Type
malfunction
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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 not possible as no lot number was provided.All information reasonably known as of 18-nov-2020 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, inc.Complaint database and identified as complaint (b)(4).
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Event Description
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It was reported one device had a small hole just below the balloon so when feeding in jejunal port it came out g-port.Additional information received 27-oct-2020 stated the patient was experiencing persistent vomiting after tube feeding.An internal breakage found allowing contrast in jejunal port to leak into the gastric side of the device.A new tube was placed.A computed tomography (ct) was performed the following day for nausea and vomiting.The tube appeared in the proper position.
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Manufacturer Narrative
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The investigation concluded that without a sample functional evaluation could not be performed in order to confirm or duplicate the reported incident.A root cause could not be determined.All information reasonably known as of 18-dec-2020 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, inc.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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