|
Catalog Number UNKNOWN POWER PORT |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
|
Patient Problem
Phlebitis (2004)
|
Event Date 08/25/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
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.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.Device not returned.
|
|
Event Description
|
The following adverse event was identified in a study 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 phlebitis reported in 1 patient during the use of the powerport clearvue slim implantable port product (unknown product code).Events range in dates from june 17, 2017-july 26, 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 these events is available.
|
|
Event Description
|
This complaint will contain the arrhythmia event identified in the retrospective multi-centre analysis of bd port implants using mayo clinic ehrs drafted by global clinical affairs for product powerport clearvue slim implantable port (unknown product code).This report was generated to capture the use of 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.Events range in dates from june 17, 2017-july 26, 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.Mayo has stated that all adverse event information was initially reported to bd at the time of occurrence therefore no additional information would be provided.No part or lot numbers were provided and no devices were returned for evaluation at this time of the study.
|
|
Manufacturer Narrative
|
H10: the event reported in the initial mfr report # 3006260740-2022-03714 was for the reported event of phlebitis.Following discussion with fda mdr leadership, one mdr will be filed per event; therefore, the event of phlebitis has been corrected in mfr report #3006260740-2022-04541.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.
|
|
Search Alerts/Recalls
|
|
|