Model Number 364815 |
Device Problem
Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2022 |
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.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device expiration date: unknown.Device manufacture date: unknown.Oem manufacturer: the manufacturing location for this product is jabil.This site is an oem manufacturing site.(b)(4).
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Event Description
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It was reported when using the bd vacutainer® one use holder the screw thread does not fit.During the sampling when the tube is put in place, this makes the needle jump off the screw.The following information was provided by the initial reporter.The customer stated: on many parts, the pump bodies are not all "drilled".The location of the needle is not done.Therefore it is impossible to fix the sampling system.On other parts, the screw thread does not fit.During the sampling when the tube is put in place, this makes the needle jump off the screw, which causes exposure to blood and discomfort for the sampler and especially for our patients.".
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Manufacturer Narrative
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The following fields have been updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 04-jan-2023.H.6.Investigation summary: bd received 4 samples and 3 photos for investigation.The photos were reviewed and the indicated failure modes for inability to attach / separates were observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure modes for inability to attach / separates with the incident lot were observed.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 has been confirmed for the indicated failure modes inability to attach / separates.Bd determined that the root cause of the indicated failure modes was because there was excess plastic over the thread bowl area on the device.This is caused by cavities in the production process getting blocked with material.This issue is rectified by cleaning the tool of excess plastic or replacing the cavity in the tool.Retain samples are then checked back to three clear boxes and any product found with the defect is scrapped.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 bd vacutainer® one use holder the screw thread does not fit.During the sampling when the tube is put in place, this makes the needle jump off the screw.The following information was provided by the initial reporter.The customer stated: on many parts, the pump bodies are not all "drilled".The location of the needle is not done.Therefore it is impossible to fix the sampling system.On other parts, the screw thread does not fit.During the sampling when the tube is put in place, this makes the needle jump off the screw, which causes exposure to blood and discomfort for the sampler and especially for our patients.".
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Search Alerts/Recalls
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