C.R. BARD, INC. (BASD) -3006260740 POWERPORT VUE M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1808062 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 04/08/2024 |
Event Type
Injury
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Event Description
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It was reported through litigation process that sometime post a port placement, the patient allegedly developed thrombosis.However, the current status of the patient is unknown.
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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 device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the reported thrombosis issue as no objective evidence was provided for review.Furthermore, clinical conditions alleged in the complaint cannot be confirmed.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.H11: section a through f ¿ the information provided by bd represents all 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 through the litigation process that three months and twenty six days post a port placement via the left internal jugular vein, the patient allegedly developed with thrombosis and occlusion of the port.It was further reported that patient developed with port infection.Reportedly, the infected port was removed and new port has been implanted.However, the current status of the patient is unknown.
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2022), g2, g3, h6 (patient) h11: b3, b5, d4 (medical device lot number), h6 (device, result, conclusion) 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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