HALYARD HEALTH MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT - 16 FR, 2.0 CM; DH EF BALLOON TUBES PRODUCTS
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Model Number 0270-16-2.0-22 |
Device Problem
Split (2537)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible, as no valid lot number has been provided.All information reasonably known as of 22 jun 2018 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 halyard health 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 halyard health.Halyard health 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 halyard health complaint database and identified as (b)(4).Device not returned.
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Event Description
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It was reported that the feeding tube split inside the patient, and the jejunal feed is now getting into the patient's stomach.No further information has been provided at this time.
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Manufacturer Narrative
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Correction: based on information received from the reporter, the product info has been updated.The device history record for lot aa7038n21 was reviewed and the product was produced according to product specifications.All information reasonably known as of 16 aug 2018 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 halyard health 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 halyard health.Halyard health 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 halyard health complaint database and identified as complaint (b)(4).
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