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Catalog Number 6396190 |
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 11/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.Device not returned.
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Event Description
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It was reported that some time post dialysis catheter placement, the lumen material was allegedly found to be splayed.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation, one electronic photo was provided for review.The photo shows one glidepath dialysis catheter implanted in a patient body.Sutures were noted on the bifurcation and insertion site.One of the extension leg was found deformed near the bifurcation.Further both the extension leg appeared emulsifies and appeared in milky white colour.Therefore the investigation is confirmed for the reported stretched and identified material deformation and material opacification issues as deformation and bulging was noted on the extension leg just distal to the bifurcation.Further both the extension legs of the catheter appeared emulsified.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: 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.H3 other text: device not returned.
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Event Description
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It was reported that some time post dialysis catheter placement, the lumen material was allegedly found to be splayed.There was no reported patient injury.
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Event Description
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It was reported that some time post dialysis catheter placement, the lumen material was allegedly found splayed.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation, one electronic photo was provided for review.The photo shows one glidepath dialysis catheter implanted in a patient body.Sutures were noted on the bifurcation and insertion site.One of the extension leg was found deformed near the bifurcation.Further both the extension leg appeared opacified and appeared in milky white colour.Therefore the investigation is confirmed for the reported stretched and identified material protrusion and material opacification issues as deformation and bulging was noted on the extension leg just proximal to the bifurcation.Further both the extension legs of the catheter appeared opacified.A definitive root cause for the reported failure could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: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.H3 other text : device not returned.
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Search Alerts/Recalls
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