C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1608052 |
Device Problems
Fluid/Blood Leak (1250); Blocked Connection (2888)
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Patient Problems
Extravasation (1842); Pain (1994); Swelling/ Edema (4577)
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Event Date 03/14/2024 |
Event Type
Injury
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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 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.H10: d4 (expiry date: 03/2025).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 that sometimes post a port placement, the patient allegedly experienced swelling, pain, warmth and tenderness in the neck and under arm.Reportedly the nurse was unable to locate the septum of the port to access it.It was further reported that results of the positron emission tomography scan showed extravasation of isotope left adjacent to the port.Port was removed.The current status of the patient is unknown.
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Search Alerts/Recalls
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