C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER, SINGLE-LUMEN, 6.6F; CHRONIC CATHETERS
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Catalog Number 0600540CE |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problems
Dyspnea (1816); Skin Inflammation/ Irritation (4545)
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Event Date 03/01/2021 |
Event Type
Injury
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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 broviac cv catheter, single-lumen, 6.6f that are cleared in the us.The pro code and 510 k number for the broviac cv catheter, single-lumen, 6.6f are identified.As the lot number for the device was not provided, a review of the device history records could not 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.
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Event Description
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It was reported that post catheter placement, the catheter hub allegedly had a leakage and break.It was further reported that the patient experienced eczema and shortness of breath.The current status of the patient was unknown.
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Event Description
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It was reported that post catheter placement, the catheter hub allegedly broke and medication leaked.It was further reported that the patient developed shortness of breath and eczema due to the decrease of medication administered.Reportedly, the damaged catheter was repaired.The patient status is unknown.
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the broviac cv catheter, single-lumen, 6.6f that are cleared in the us.The pro code and 510 k number for the broviac cv catheter, single-lumen, 6.6f are identified in d2 and g4.H10: manufacturing review: a lot 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.The investigation is inconclusive for the reported catheter break and leak issue.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.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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Search Alerts/Recalls
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