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Model Number 021116 |
Device Problems
Fitting Problem (2183); Device Handling Problem (3265)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2023 |
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.H3 other text : the device was not returned.
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Event Description
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It was reported that customer had bard followers and filiforms but the tips were not connecting.(pcn 021114, pcn 021112, pcn 021116, pcn 021118, pcn 021120 , pcn 021122, pcn 021124, pcn 021316, pcn 021100, pcn 021905, pcn 021906, pcn 022105).
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Manufacturer Narrative
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Per additional information received, bd has determined that this mdr event is not reportable.Section a through f - the information provided by bd represents all of 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 customer had bard followers and filiforms but the tips were not connecting.(pcn 021114 , pcn 021112 , pcn 021116 , pcn 021118 , pcn 021120 , pcn 021122 , pcn 021124 , pcn 021316 , pcn 021100 , pcn 021905 , pcn 021906 , pcn 022105).Per additional information received via email on 06jul2023, it was reported that customer thought there might have been some confusion with this.There was not issue with the product itself and they had mismatched followers and filiform on hand which caused an issue, on their end they figured out the issue and just had the wrong products.
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Search Alerts/Recalls
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