C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 1808560 |
Device Problems
Fracture (1260); Material Separation (1562); Migration (4003)
|
Patient Problems
Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 10/16/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
H10: 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.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.H3 other text : device not returned.
|
|
Event Description
|
It was reported that sometime post a port placement, the catheter allegedly fractured at the level of the clavicle.It was further reported that there was an intravascular catheter fragment allegedly migrated and embolized into the right atrium.Reportedly, the catheter fragment was retrieved without complications.The current status of the patient was unknown.
|
|
Search Alerts/Recalls
|
|
|