C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT, BROVIAC SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0606100 |
Device Problems
Disconnection (1171); Migration or Expulsion of Device (1395); Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/19/2020 |
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 through the litigation process that sometime post a port placement via the right internal jugular vein, the port was allegedly migrated to the right ventricle.Reportedly, the port was removed.The current status of the patient was unknown.
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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 device was not returned for evaluation.Medical records were provided and reviewed.Approximately two months post port placement, x ray chest appeared to have disassociation of the catheter portion of the patient¿s port from its hub with migration of the catheter portion of the port to the level of the right ventricle.On the same date, endovascular port catheter retrieval and left chest port replacement was performed, the old port was freed from surrounding tissues and removed.The new port catheter was attached to tunneling device and tunneled from the port pocket to the venotomy site.After new port placement the port was aspirated and flushed easily.The patient tolerated the procedure well and there were no immediate complications.Therefore, the investigation is confirmed for the reported disconnection and migration.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 04/2023).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 through the litigation process that two months post port placement via the right internal jugular vein, for administration of chemotherapy in treatment of breast cancer, the catheter portion of the port was allegedly found to be disassociated from its hub with migration of the catheter portion of the port to the level of the right ventricle.Reportedly, the port was removed and replaced.The current status of the patient was unknown.
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Search Alerts/Recalls
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