C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1716000J |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Pain (1994); Swelling/ Edema (4577)
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Event Date 09/23/2021 |
Event Type
Injury
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Event Description
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It was reported that twelve days post port device implant, the patient allegedly experienced pain, swelling, fever and redness upon administration of drugs.The device was removed off the patient.The current status of the patient is unknown.
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Manufacturer Narrative
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The catalog number identified has not been cleared in the us but is similar to the power port slim implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the powerport slim implantable port, chronoflex single-lumen, 6f products are identified.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport implantable port attached to a catheter was returned for evaluation.Gross visual and functional testing were performed.The investigation is inconclusive for the reported issue as the exact circumstances at the time of reported event is unknown and however clinical conditions cannot be replicated to confirm these failures.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.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: the catalog number identified in section d4 has not been cleared in the us but is similar to the power port slim implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the powerport slim implantable port, chronoflex single-lumen, 6f products are identified in d2 and g4.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.
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Event Description
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It was reported that twelve days post port device implant, the patient allegedly experienced pain, swelling, fever and redness upon administration of drugs.The device was removed off the patient.The current status of the patient is unknown.
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Search Alerts/Recalls
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