C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 5618000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Aneurysm (1708); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994)
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Event Date 12/02/2020 |
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 (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 post port device implant, the patient allegedly experienced pain, redness, swelling, bulging of neck veins, blisters and necrotic skin.The procedure was completed using another device.The current status of the patient is unknown.
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Event Description
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It was reported that post port device implant, the patient allegedly experienced pain, redness, swelling, bulging of neck veins, blisters and necrotic skin.The procedure was completed using another device.The current status of the patient is unknown.
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Manufacturer Narrative
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Manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: the device was not returned for evaluation.Therefore, the reported pain,redness,swelling,bulging of neck veins and necrotic skin cannot be confirmed.A definitive root cause could not be determined 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.D4: (expiry date: 09/2021).H11: section a through f ¿ the information provide 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.Device not returned.
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Search Alerts/Recalls
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