Model Number BC2755 |
Device Problems
Detachment Of Device Component (1104); Device Issue (2379)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The complaint bc2755-20 intermediate infant oxygen therapy nasal cannula is manufactured by salter labs in (b)(4), for fisher & paykel healthcare.We are still endeavouring to retrieve the bc2755-20 cannula.We will provide a follow up report upon completion of our investigation.
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Event Description
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A healthcare facility in (b)(6) reported to via a fisher & paykel healthcare (fph) field representative that the connection between the prongs and tubing of a bc2755-20 intermediate infant oxygen therapy nasal cannula had split.This was found after 2 days of use.There was no patient consequence.
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Manufacturer Narrative
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(b)(4).The complaint (b)(4) intermediate infant oxygen therapy nasal cannula is manufactured by (b)(4), for f&p.Method: the complaint (b)(4) cannula was returned to f&p in new zealand for evaluation where it was visually inspected.Result: visual inspection revealed that the left tube had detached from the nose piece and was coated with a sticky substance.The right tube was attached to the nose piece and was coated with a sticky substance.Conclusion: during manufacture by (b)(4), a bonding agent is applied to the outside surface of the tube and then inserted into the nasal interface.It appears that either insufficient bonding agent was applied to the cannula during manufacturing or that the bonding material applied had not bonded properly.A cannula from a similar complaint was sent to salter labs and they implemented a number of corrective actions including improvement of the gluing process and evaluating and replacing any damaged glue dispensers.The manufacturer of this device has been notified of this complaint and is conducting their own investigation.
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Event Description
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A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that the connection between the prongs and tubing of a bc2755-20 intermediate infant oxygen therapy nasal cannula had split.This was found after 2 days of use.There was no patient consequence.
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Search Alerts/Recalls
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