BARD ACCESS SYSTEMS M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0603880C |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombus (2101)
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Event Date 02/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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The catalog number has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products is identified.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 (09/2021).
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Event Description
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It was reported that approximately five months post port placement in the right chest wall through the right internal jugular vein, the patient allegedly developed thrombosis that was identified under ultrasound.It was further reported that the port was successfully removed under local anesthesia after thrombolytic therapy.The patient was reportedly discharged the same day.
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Manufacturer Narrative
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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, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products is identified in d2 and g5.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.The investigation is inconclusive for the reported thrombosis.A 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.H10: d4 (expiry date: 09/2021),g4.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 approximately five months post port placement in the right chest wall through the right internal jugular vein, the patient allegedly developed thrombosis that was identified under ultrasound.It was further reported that the port was successfully removed under local anesthesia after thrombolytic therapy.The patient was reportedly discharged the same day.
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Search Alerts/Recalls
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