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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Model Number 1808062 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Sepsis (2067)
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Event Date 04/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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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.(expiration date: 04/2023).
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Event Description
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It was reported that during a port placement procedure, the patient alleged felt sick and had high fever.It was further reported that the patient allegedly had staph and sepsis infection.It was further reported that the patient had no port and the infection had occurred from the port.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 required as this is the only complaint reported to date for this product and lot.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: b5, d4 (expiration date: 04/2023).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 procedure, the patient allegedly experienced illness with a high fever.It was further reported that the patient allegedly developed a staph and sepsis infection.Reportedly, the device was removed from the patient while in the hospital.The hospital tested the device and identified that the infection was present at the tip of the port.The current status of the patient was unknown.
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Search Alerts/Recalls
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