BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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Model Number 367886 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 bd vacutainer® lithium heparinn (lh) 95 usp units blood collection tubes, the device experienced.This event occurred 6 times.The following information was provided by the initial reporter.The customer stated: in the emergency clinical laboratory of (b)(4) hospital, when 367886 was used to enter the assembly line, the 367886 cap was not completely removed, the rubber plug stopped the needle, and the equipment was shut down for many times.This happened many times on october 14th, which seriously affected the normal emergency work, resulting in the extension of the report issuing time and repeated contact with the sample adding needle.
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Event Description
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It was reported when using the bd vacutainer® lithium heparinn (lh) 95 usp units blood collection tubes, the device experienced.This event occurred 6 times.The following information was provided by the initial reporter.The customer stated: in the emergency clinical laboratory of shanghai sixth people's hospital, when 367886 was used to enter the assembly line, the 367886 cap was not completely removed, the rubber plug stopped the needle, and the equipment was shut down for many times.This happened many times on october 14th, which seriously affected the normal emergency work, resulting in the extension of the report issuing time and repeated contact with the sample adding needle.
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples, but one (1) photo was provided for investigation.The photo was reviewed and the indicated failure mode for closure separation was observed.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and ten (10) retention samples were evaluated by functional testing.The issue of closure separation and was not 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 mode of closure separation.Bd was not able to identify a root cause for the indicated failure mode.
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