Catalog Number UNKNOWN |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Event Description
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It was reported that unspecified bd infusion set had loose connection the following information was received by the initial reporter with the following verbatim: the picture below shows the difference between the bd and braun extension set.The braun is able to seat securely into the olympus biopsy port whereas the bd is not able to do this.The braun spin adapter retracts to allow the male end to insert into the biopsy port.We have found that using the extension set provides a more stable bal/wedge specimen collection during the bronchoscopy.If you have another one that does, please let us know.
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Event Description
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No additional information was provided.
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Manufacturer Narrative
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No product or photo was returned by the customer.The customer complaint of connection issues could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the material and lot number are unknown.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
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Search Alerts/Recalls
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