C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1608062 |
Device Problems
Disconnection (1171); Obstruction of Flow (2423); Migration (4003)
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Patient Problems
Erythema (1840); Pain (1994); Thrombosis/Thrombus (4440)
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Event Date 06/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 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: 04/2022).
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Event Description
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It was reported that post port placement, the patient allegedly experienced pain and erythema around the port site.It was further reported that the patient allegedly developed a thrombus and tricuspid regurgitation.A ct chest angiogram revealed pulmonary arteriovenous malformation which was identified and treated by an embolization procedure.The patient was suggested to undergo additional imaging, testing and anti-coagulant therapy for catheter associated atrial thrombus.The patient's current status 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 physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause could not be determined based upon the 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: 04/2022).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 that post port placement, the patient allegedly experienced pain and erythema around the port site.It was further reported that the patient allegedly developed a thrombus and tricuspid regurgitation.A ct chest angiogram revealed pulmonary arteriovenous malformation which was identified and treated by an embolization procedure.The patient was suggested to undergo additional imaging, testing and anti-coagulant therapy for catheter associated atrial thrombus.The patient's current status was unknown.
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Search Alerts/Recalls
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