Model Number 802010 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that patient stated that one of the items was punctured.The head had a puncture through the tap.Per follow up via email received on (b)(6)2023, customer stated that no issue with a patent.The product arrived with a puncture in the package.
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Manufacturer Narrative
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The reported event was confirmed cause unknown.1 sample were confirmed to exhibit the reported failure.Visual evaluation of the returned photo sample noted one unopened (with original packaging), bardia insertion tray.Visual inspection of the photo sample noted a hole puncture in the package.This does not meet specification which states "no damage or holes on trays or tyvek are allowed".A potential root cause for this failure mode could be ¿material handling." the lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labelling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that patient stated that one of the items was punctured.The head had a puncture through the tap.Per follow up via email received on 11jul2023, customer stated that no issue with a patent.The product arrived with a puncture in the package.
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Search Alerts/Recalls
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