Catalog Number UNK POWERLINE |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Autoimmune Reaction (1733); Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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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 few days after chronic catheter placement, the patient allegedly experienced a mast cell activation syndrome.It was further reported that the patient developed an infection a few days after the device was placed.Reportedly, the catheter was removed from the patient.Current status of patient is unknown.
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Manufacturer Narrative
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H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Therefore, the reported infection and allergic reaction cannot be confirmed.A 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.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 that few days after chronic catheter placement, the patient allegedly experienced a mast cell activation syndrome.It was further reported that the patient developed an infection, soreness and swelling at the site of device a few days after the device was placed.Reportedly, patient developed hives on neck with an elevated blood pressure.The device was removed from the patient and the current status of patient is unknown.
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Search Alerts/Recalls
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