C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 5608062 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Bacterial Infection (1735); Unspecified Infection (1930); Sepsis (2067)
|
Event Date 04/29/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Medical records were not provided.Therefore, the investigation is inconclusive for the reported clinical condition as no objective evidence was provided for review.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.The information provided 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.
|
|
Event Description
|
It was reported through litigation process that sometime post a port placement, the patient allegedly developed infection.However, the current status of the patient is unknown.
|
|
Manufacturer Narrative
|
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 11/2021).H11: section a through f ¿ the information provided 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.H3 other text : device not returned.
|
|
Event Description
|
It was reported through the litigation process that one year, four months, and twenty-eight days post a port placement via the right internal jugular vein, the patient was allegedly diagnosed with bacteremia and the blood culture test resulted positive for methicillin sensitive staphylococcus aureus bacterial infection.It was further reported that the patient allegedly developed with sepsis secondary to methicillin sensitive staphylococcus aureus bacteremia as a result of the defective infected port.Reportedly, the infected port was removed and replaced.The current status of the patient is unknown.
|
|
Search Alerts/Recalls
|
|
|