Catalog Number 360057 |
Device Problems
Difficult to Insert (1316); Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported when using the tube k2edta plh 13x75 4.0 plbl lav br, the device experienced stopper creep out or loose closure, stopper popping out of the tube, and difficulty when trying to pierce through the stopper.This event occurred 100 times.The following information was provided by the initial reporter.The customer stated: further reports that it doesn't happen only to sst tubes, but also with purple cap tubes.By "caps are getting loose", customer means: it's a difficult to insert stopper issue; it's a stopper creepout issue; it's a stopper pop off issue;.
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Manufacturer Narrative
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The following fields have been updated with additional information: d10 device available for eval? yes.D10 returned to manufacturer on: 01-dec-2022.H6: investigation summary: bd received 30 samples from the customer in support of this investigation.The samples were visually evaluated and functionally tested and there were no issues related to stopper function.Additionally, 200 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to stopper function as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode stopper function.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported when using the tube k2edta plh 13x75 4.0 plbl lav br, the device experienced stopper creep out or loose closure, stopper popping out of the tube, and difficulty when trying to pierce through the stopper.This event occurred 100 times.The following information was provided by the initial reporter.The customer stated: further reports that it doesn't happen only to sst tubes, but also with purple cap tubes.By "caps are getting loose", customer means: it's a difficult to insert stopper issue; it's a stopper creepout issue; it's a stopper pop off issue.
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Search Alerts/Recalls
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