Catalog Number 1115 |
Device Problem
Kinked (1339)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Visual inspection of the product involved in the complaint was performed on two pictures provided by the customer.Some marks on the tube were observed, however, no issues can be observed that can lead this customer complaint.In order to perform a proper and thorough investigation to confirm the alleged defect reported and determine a root cause, it is necessary to evaluate the sample involved in this complaint.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.The dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.If the sample becomes available this investigation will be updated with the evaluation results.Teleflex will continue to monitor and trend for complaints of this nature.
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Event Description
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Customer complaint alleges "tubing kinks where it comes off the wall and collapses making it useless to deliver o2 to patient." alleged defect reported as detected during use.There was no report of patient impact or consequence.Customer submitted photos with the complaint.
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Manufacturer Narrative
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Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and no kinked tubing was observed.The received tubing was found to be within specification.The complaint could not be confirmed as no issues were found.
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Event Description
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Customer complaint alleges "tubing kinks where it comes off the wall and collapses making it useless to deliver o2 to patient." alleged defect reported as detected during use.There was no report of patient impact or consequence.Customer submitted photos with the complaint.
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Search Alerts/Recalls
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