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Catalog Number 6396240 |
Device Problems
Material Opacification (1426); Stretched (1601); Material Deformation (2976); Material Protrusion/Extrusion (2979)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/11/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a dialysis catheter placement procedure, the catheter was allegedly opacified.It was further reported that the catheter allegedly bulged at the hilt.There was no reported patient injury.
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiration date: 02/2024) 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 : device not returned.
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 24 cm glidepath d/l catheter was returned for evaluation.One photo was also provided for review.Visual, functional and microscopic evaluations were performed on the returned device.Opacification was noted to the extension leg near the bifurcation area.Bulge appearance was noted to both extension legs and the proximal end of the catheter body was also noted to be bulge and flattened.Therefore the investigation is confirmed for the reported material opacification and bulging issues.The definitive root cause for the reported event could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 02/2024), h2, g3.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 : see h10.
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Event Description
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It was reported that during a dialysis catheter placement procedure, the catheter was allegedly opacified.It was further reported that the catheter allegedly bulged at the hilt.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported catheter opacification and catheter bulging issues as no objective evidence was provided for review.The definitive root cause for the reported event could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 02/2024), g3, h6 (method).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 during a dialysis catheter placement procedure, the catheter was allegedly opacified.It was further reported that the catheter allegedly bulged at the hilt.There was no reported patient injury.
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Search Alerts/Recalls
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