Model Number IPN049847 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2021 |
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 could not be conducted since the lot number of the device was not provided.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Corrected data:.
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Event Description
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It was reported an "intubated patient had bite block in his mouth.Upon doing mouth care at 6 pm, the pca helping me noticed that the green part that goes between patient's teeth was in his mouth and was no longer attached to the long white part that comes out of the mouth.The white part was found in the bed by patient's neck".No patient injury or harm reported.No medical intervention reported.Patient condition reported as "fine".
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Manufacturer Narrative
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Qn#(b)(4).The sample was returned by the customer and sent to the manufacturing site for analysis.The manufacturing site reports: "the customer complaint is confirmed since a broke sample of product code 1140 was received for evaluation.While performing the visual inspection to received sample, part of the handle was observed on the bite block which indicates that the damage issue could have been generated due to an incorrect use of the device.What the customer is reporting as "broken issue" it is actually a damaged on the device." although the complaint is confirmed, a root cause could not be established.
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Event Description
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It was reported an "intubated patient had bite block in his mouth.Upon doing mouth care at 6 pm, the pca helping me noticed that the green part that goes between patient's teeth was in his mouth and was no longer attached to the long white part that comes out of the mouth.The white part was found in the bed by patient's neck".No patient injury or harm reported.No medical intervention reported.Patient condition reported as "fine".
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Search Alerts/Recalls
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