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Catalog Number UNK CHRONIC CATHETER |
Device Problem
Malposition of Device (2616)
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Patient Problems
Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2023 |
Event Type
Injury
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Manufacturer Narrative
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H10: as the lot number for the device was not provided, a review of the device history records could not 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.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 during a chronic catheter placement procedure, the catheter allegedly ended up malpositioned in the mediastinum and not in the superior vena cava.Reportedly, the catheter was removed.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 physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported catheter malposition issue as no objective evidence was provided for review.The definitive root cause 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: b5, g3 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 during a chronic catheter placement procedure, it was identified that the chronic catheter was mispositioned outside of the intended treatment site.Reportedly, the patient experienced a prolonged hospital stay for observation, and removal of the mispositioned catheter a few days later without further consequence to the patient.There was no reported patient injury.
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Manufacturer Narrative
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H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.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 malposition issue as no objective evidence was provided for review.The definitive root cause 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 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.
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Event Description
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It was reported that during a chronic catheter placement procedure, it was identified that the chronic catheter was allegedly mispositioned outside of the intended treatment site.It was further reported that the patient allegedly experienced vessel perforation.Reportedly, the patient required prolonged hospital stay for observation, and removal of the mispositioned catheter a few days later without further consequence to the patient.The current status of the patient is unknown.
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Search Alerts/Recalls
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