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Catalog Number 33616 |
Device Problem
Component Misassembled (4004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2023 |
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 there was no orange part in the beginning of the foley catheter.That is, the probe was missing a piece.The probe was not used in patient, the probe was inside the original closed packaging.
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Manufacturer Narrative
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The reported event was confirmed manufacturing related.The device had not met specifications.Visual evaluation of the returned sample noted one unopened (without original packaging), silastic foley catheter.Visual inspection of the sample noted the inflation valve cap was missing from the inflation arm on the returned sample, also noted the inflation valve was observed to be positioned at an angle but fit securely in the inflation funnel, the foley catheter was inflated with 10 ml of d.I water and no issue observed.With the syringe attached the balloon deflated passively as intended.This does not meet the specifications which states "missing/incorrect components are not allowed".A potential root cause for this failure mode could be ¿machine malfunction¿.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review was not performed because labelling could not have prevented the reported failure.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 there was no orange part in the beginning of the foley catheter.That is, the probe was missing a piece.The probe was not used in patient, the probe was inside the original closed packaging.
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Search Alerts/Recalls
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