C.R. BARD, INC. (BASD) -3006260740 SITE-RITE 8 ULTRASOUND; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
|
Back to Search Results |
|
Catalog Number 9770501 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/06/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and is pending evaluation.Results are expected soon.
|
|
Event Description
|
The cord on the probe is pulling away at the strain relief, exposing wiring.No other information was provided.
|
|
Manufacturer Narrative
|
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.The device was returned to service facility for evaluation.During evaluation, the reported issue of the cord is pulling away at the strain relief was confirmed.The probe wires are separated at the strain relief at the probe end.The root cause is use related.
|
|
Event Description
|
The cord on the probe is pulling away at the strain relief, exposing wiring.No other information was provided.
|
|
Search Alerts/Recalls
|
|
|