C.R. BARD, INC. (BASD) -3006260740 HICKMAN PORT SINGLE LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0603880C |
Device Problems
Fluid/Blood Leak (1250); Stretched (1601); Material Protrusion/Extrusion (2979)
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Patient Problems
Extravasation (1842); Pain (1994)
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Event Date 06/27/2023 |
Event Type
Injury
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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 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products are identified in d2 and g4.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.However, an image was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 08/2024).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.H3 other text : device not returned.
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Event Description
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It was reported that three months and thirteen days post a port placement via the right internal jugular vein, the neck of the port was allegedly found to be swollen.It was further reported that a chest x-ray examination was performed which showed extravasation of contrast agent at the vascular puncture site, and a catheter rupture was suspected.Furthermore, the patient allegedly experienced pain.Reportedly, the use of the port was suspended for safety reasons.The current status of the patient is unknown.
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