BARD ACCESS SYSTEMS M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMEN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0603880C |
Device Problems
Loss of or Failure to Bond (1068); Fracture (1260); Migration or Expulsion of Device (1395); Suction Problem (2170)
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Patient Problem
Injury (2348)
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Event Date 04/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review 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.Expiry date: (08/2021).The catalog number has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f is identified.
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Event Description
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It was reported that during a palliative chemotherapy treatment, the catheter allegedly migrated to pulmonary artery and dislodged.The catheter was removed through surgery.The patient was transferred to cardiothoracic surgery for further treatment.The patient status was unknown.
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Manufacturer Narrative
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H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the device was not returned for evaluation.Therefore, the reported catheter dislodgement, catheter migration, no blood return issue and catheter obstruction cannot be confirmed.A device history record review could not be performed as the lot number is unknown.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.H10: d4 (expiry date: 08/2021),g4,h6(device: 2423).H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickmen single-lumen, 6.6f is identified in d2 and g5.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 palliative chemotherapy treatment, the catheter allegedly migrated to pulmonary artery and dislodged.The catheter was removed through surgery.The patient was transferred to cardiothoracic surgery for further treatment.The patient status was unknown.
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Search Alerts/Recalls
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