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Catalog Number UNKNOWN POWER PORT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pneumothorax (2012)
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Event Date 08/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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This initial mdr is being submitted post-discussions with fda mdr leadership.The due date for this mdr is november 11, 2022.As the lot number for the device was not provided, a review of the device history records could not be performed.The samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigations of the reported events are inconclusive.Based upon the available information, the definitive root cause for these events is unknown.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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The following adverse events were identified utilizing electronic health record data provided by mayo clinic to bd for the purpose of evaluating clinical outcomes for bardtm long-term implantable ports (power and non-power) used in a contemporary real-world cohort of patients.This mdr will capture the pneumothorax reported during the use of the powerport m.R.I.Implantable port product (unknown product code).Events range in dates from (b)(6) 2017-(b)(6) 2021.Potential device-related adverse events were detected using the presence of diagnosis and procedure codes occurring on the date of port-implant or up to the date of a terminal event.To ensure privacy, the data have undergone statistical anonymization to preclude reidentification with high probability.This de-identification process includes all dates and times, which are randomly adjusted.Therefore, any individual procedure, patient or event information is not available.No part or lot numbers are available, and no devices were returned for evaluation at the time of the study.No additional information regarding this event is available.
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Search Alerts/Recalls
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