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
Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problems
Bacterial Infection (1735); Pain (1994); Swelling/ Edema (4577)
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Event Date 05/09/2022 |
Event Type
Injury
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Event Description
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It was reported through the litigation process that approximately one month and twenty-two days post port placement after being diagnosed with cancer in right breast.It was reported that the device allegedly had a leak due to the silicone cracking.It was further reported that the patient allegedly experienced pain, swelling and redness that began to travel from front right shoulder up to the neck, and the port was removed due to these complications.Reportedly the port site was ruptured from constant infection and the patient was tested positive for methicillin-susceptible staphylococcus aureus blood infection.Infection medications were provided for treatment.The current status of the patient is unknown.
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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: 03/2023.
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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.The definitive root cause could not be determined based upon 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 (expiration date: 03/2023).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.
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Event Description
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It was reported through the litigation process that one month and twenty-two days post port placement at left side for a patient diagnosed with cancer on right side of breast, the device allegedly began to leak due to silicone catheter crack.It was further reported that the patient allegedly experienced swelling during treatment.Reportedly, the port system was removed and the patient was diagnosed with methicillin-sensitive staphylococcus aureus infection after hospitalization at the port removal site.The patient was subsequently treated with prescribed additional medication sprayed into the body for swelling and infection.The procedure was completed using another device.The current status of the patient is unknown.
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Search Alerts/Recalls
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