C.R. BARD, INC. (BASD) -3006260740 SITE RITE 8 ULTRASOUND SYSTEM 20MM CUE LINEAR PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/20/2023 |
Event Type
malfunction
|
Event Description
|
It was reported the probe's sheathing separated from the probe head and now all of the wires are showing.
|
|
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 device has not been received by the manufacturer for evaluation.
|
|
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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the cue probe was visually inspected upon receipt and was found to be in poor physical condition.The reported of exposed wires is confirmed, the cord is separated from the strain relief exposing the wires.The root cause is due to device use.H3 other text : evaluation findings are in section h11.
|
|
Event Description
|
It was reported the probe's sheathing separated from the probe head and now all of the wires are showing.
|
|
Search Alerts/Recalls
|
|
|