BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® Z (NO ADDITIVE) PLUS URINE TUBE; TRANSPORT CULTURE MEDIUM
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Catalog Number 364915 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Information (3190)
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Event Date 04/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
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Event Description
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It was reported that after use of the bd vacutainer® z (no additive) plus urine tube when cap is replaced, it sometimes happens that the cap falls down.There were 50 occurrences.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: urine tube was opened for collection, then when cap is replaced, it sometimes happens that the cap falls down.Hemogard closure drops off.
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Manufacturer Narrative
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H.6.Investigation: investigation summary: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the stopper was separated from the tube.Additionally, testing of the customer samples was performed and stopper popoff was not observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for stopper popoff with the incident lot was observed.Additionally, testing of the customer samples was conducted and stopper popoff was not observed.Root cause description: based on the investigation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd 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 that after use of the bd vacutainer® z (no additive) plus urine tube when cap is replaced, it sometimes happens that the cap falls down.There were 50 occurrences.Foreign complaint the following information was provided by the initial reporter, translated from german to english: urine tube was opened for collection, then when cap is replaced, it sometimes happens that the cap falls down.Hemogard closure drops off.
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Search Alerts/Recalls
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