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Catalog Number 5-15401 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported when the customer "went to remove the bronch adaptor from the circuit, upon pulling, a piece snapped off of the bronch adaptor, getting stuck inside the etco2 cuvette.Piece could not be pushed back together, so cuvette was removed from circuit so patient could be placed back on the vent".Vent circuit replaced.Patient reported as fine.
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Event Description
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It was reported when the customer "went to remove the bronch adaptor from the circuit, upon pulling, a piece snapped off of the bronch adaptor, getting stuck inside the etco2 cuvette.Piece could not be pushed back together, so cuvette was removed from circuit so patient could be placed back on the vent".Vent circuit replaced.Patient reported as fine.
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Manufacturer Narrative
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(b)(4).The customer returned one unit 5-15401 sher-i-swiv/fo for investigation.Additionally, the customer returned one y connector.The returned samples were visually examined with and without magnification.Visual examination revealed that the 15m part of the cobb connector was detached and stuck inside the y connector.The returned sample was sent to the manufacturing site for further investigation.Dimensional inspection could not be performed on the returned sample since the sample was damaged.However, production representative samples were tested.All 30 pieces of cobb connector tested by the manufacturing site were found to be within the specifications.No dimensional defects were observed with the production representative samples.Functional inspection could not be performed based on the condition of the returned sample.The returned sample was sent to the manufacturing site for further investigation.A pull test could not be performed on the returned sample since the 15m connector was already detached.However, a pull test was performed on current production representative samples.Fifteen samples were tested and all samples passed the pull test (withstand up to 8kg force applied without detaching).Additionally, the returned sample was able to pass a ring gauge test and the y connector was able to pass a plug gauge test.The ifu for this product states, "single use: do not reuse, reprocess or re-sterilize." "reprocessing of medical devices intended for single use only may result in degraded performance or a loss of functionality." the reported complaint of "broken/cracked - double swivel connector" was confirmed based upon the samples received.Based on the testing performed by the manufacturing site, it appears that the returned sample most likely detached due to the application of high force.This failure appears to be isolated to 5 complaints from one customer.Therefore, the root cause of this complaint is user error.An in-service request has been submitted.
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Search Alerts/Recalls
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