Model Number 364979 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2022 |
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.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported when using the bd vacutainer® urinalysis urine tube there was tube extenders with molding defects that can be used.The following information was provided by the initial reporter.The customer stated: "the tops are smaller causing the analyzer to drop the samples.".
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Manufacturer Narrative
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The following fields have been updated with additional/corrected information: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 1288661.D.4.Medical device expiration date: 2023-10-31.H.4.Device manufacture date: 2021-10-15.D.4.Medical device lot #: 1350285.D.4.Medical device expiration date: 2023-12-31.H.4.Device manufacture date: 2021-12-16.
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Event Description
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It was reported when using the bd vacutainer® urinalysis urine tube there was tube extenders with molding defects that can be used.The following information was provided by the initial reporter.The customer stated: "the tops are smaller causing the analyzer to drop the samples.".
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Event Description
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It was reported when using the bd vacutainer® urinalysis urine tube there was tube extenders with molding defects that can be used.The following information was provided by the initial reporter.The customer stated: "the tops are smaller causing the analyzer to drop the samples.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 17-mar-2022.H.6.Investigation: bd received eleven (11) samples from lot #1288661 and one (1) from lot #1350285 for investigation.The samples were evaluated by visual examination and the indicated failure mode for stopper size causing instrument issues with the incident lots were not observed, as no issues with the stoppers were identified.The stoppers were the correct size and material per the product specification.Additionally, one hundred (100) retention samples from each lot (1288661 and 1350285) from bd inventory were evaluated by visual examination and no issues were observed relating to stopper size/issues as all samples met specifications.Based on a review of the device history record for the incident lots, all product specifications and requirements for lot release were met.There were no related quality notifications.This complaint is unable to be confirmed for the indicated failure mode of stopper size causing instrument issues based on the returned and retention samples.Bd was not able to identify a root cause for the indicated failure mode.
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Search Alerts/Recalls
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